ALDI
Batavia, Illinois
Ready to lead an award-winning team? As an ALDI executive, you are responsible for driving and implementing the key initiatives that keep our customers happy and ensure our business model evolves with the needs of the company. Immerse yourself in a culture of collaboration and continuous improvement with our growing and thriving organization. Are you passionate about ensuring top-notch food safety and quality assurance? ALDI, one of America's fastest-growing retailer with an extensive array of private label products, is seeking a dynamic leader to fill the role of Director of Food Safety and Quality Assurance. This is your chance to spearhead the development and implementation of quality strategies that will shape the future of our organization. As the Director, you'll have the opportunity to drive innovation, maintain rigorous standards, and uphold our commitment to excellence in every aspect of our product offerings. Join us and be at the forefront of shaping the food industry landscape while enjoying the satisfaction of ensuring consumer trust and satisfaction. In this role the QA Director will lead the Food Safety and Quality Assurance function by defining, communicating, and coordinating the implementation of the organization's FSQA strategy to ensure that products are safe, legal and meet the quality expectations of our customers. The ideal candidate has extensive knowledge of FDA and USDA regulations and broad knowledge of Food Safety and Quality standards including GFSI, HACCP and Lean Six Sigma. Diverse knowledge of different product manufacturing technologies, ingredients, and methods as well as an educational background in Science or Engineering is preferred. Position Type: Full-Time Work Location: Batavia, IL Duties and Responsibilities: Must be able to perform duties with or without reasonable accommodation. • Leads Quality Assurance, Food Safety and Regulatory Compliance at ALDI and is responsible for planning, developing, and directing all quality assurance, food safety and regulatory policies, programs, and initiatives in accordance with quality and regulatory guidelines and requirements. • Directly accountable for the quality strategy development, implementation, and performance of ALDI Private Label Products. • Reports to leadership on quality performance, incidents, and trends. • Recruits, trains and manages a team of high performing QA staff to drive continuous improvement throughout the organization using comprehensive risk assessment, clear goals and expectations, and a focus on data analysis to identify strategic opportunities for improvement. • Recruits, relocates, and recommends qualified employees for their team; determines the appropriate training methods/courses for new hires. • Determines the salary levels for newly-hired or transferred employees reporting to them according to the established company wage structure. • Understands the overarching company strategy, while communicating and modeling the core values of the organization to create a sense of teamwork and membership among employees. • Establishes, communicates and evaluates job responsibilities and performance expectations to their team to ensure mutual understanding of desired results. • Liaises with authorities as required and serves as communication liaison between department managers and upper management to assure understanding of goals, objectives, and opportunities for improvement. • Performs root-cause analysis and other problem solving activities in order to identify and recommend effective corrective actions and process improvements. • Reports to leadership on quality issues, trends, and losses. • Establishes and communicates procedures and standards with departments in their areas of responsibility. • Oversees the appropriate resolution of serious customer concerns. • Recommends actions based on identified trends from customer feedback. • Consults with executives on the development of their team's strategy. • Makes recommendations to executives on how to improve, design, and streamline applicable policies, procedures, and practices. • Manages external consultants accordingly. • Liaises with directors in other ALDI countries to facilitate the sharing of best practices. • Manages and communicates ALDI protocol with testing agencies and third party auditors. • Keeps up to date with all legal requirements in areas of responsibility. • Contributes to the International QA Steering Committee and participates in working groups as required. • Ensures appropriate processes are implemented to verify ALDI Private Label products are safe, legal and meeting the quality expectations of our customers. • Directs their team by ensuring that all projects and tasks meet business needs as well as expectations for quality and service. • Establishes team objectives that align with the overall company strategy. • Participates in National and Specialist Committees as required to establish best practice and business consistency. • Identifies and develops company-wide and individual initiatives for their team. • Complies with ALDI privacy and security requirements and policies if job responsibilities include possible access to confidential and/or sensitive information. • Other duties as assigned. Job-specific Competencies: Knowledge/Skills/Abilities • Consistently demonstrates the ALDI Acts Competencies as outlined for the role. • Extensive working knowledge of HACCP, HARPC, FSMA, FSVP and GFSI. • Diverse knowledge of inspection and control methods, techniques, and documentation. • Ability to read, analyze, and interpret common scientific and technical journals, regulatory reports and legal documents. • Ability to accurately assess risk and provide sound organizational recommendations that incorporate quality and regulatory guidelines and reflect the needs of the business. • Ability to effectively collaborate with the company executive team and senior leadership at suppliers and third-party partners. • Working knowledge of product formulations, development, scale-up, mass production and quality control activities. • Skilled at performing root-cause analysis and other problem-solving activities to identify effective corrective action and process improvements. • Excellent communication skills (written and verbal). • Strong computer skills including quality control applications, word processing, spreadsheets and databases as may be required Gives attention to detail and follows instruction. • Understands the history, strategy, organizational authority, interdependence of job duties, products, systems and services of the company. • Ability to develop rapport, trust and open communication that enhances the growth and job performance of direct reports. • Understands cost/benefit analysis. • Ability to recommend, interpret, and/or apply company policies and procedures. • Knowledge of products and services of the company. • Understands, recognizes, and effectively manages challenges by proactively working to decrease their impact and frequency. • Knowledge of accepted industry standards and practices. • Ability to thrive in a fast-paced work environment, consistently meeting deadlines and remaining calm under pressure. • Extensive working knowledge of HACCP, HARPC, FSMA, FSVP and GFSI. • Knowledge of inspection and control methods, techniques, and documentation. • Ability to read, analyze, and interpret common scientific and technical journals, regulatory reports and legal documents. • Ability to accurately assess risk and provide sound organizational recommendations that incorporate quality and regulatory guidelines and reflect the needs of the business. • Knowledge of product formulations, development, scale-up, mass production and quality control activities. • Strong computer skills including quality control applications, word processing, spreadsheets and databases. • Knowledge of Food Safety, Food Processing, applicable USDA and FDA Regulations, Food Allergens, Crisis Management, Food Fraud, Specification Development, Quality Standards, Quality Systems, Sanitary design and Environmental Monitoring, Good Manufacturing Practices, HACCP and GFSI Certification schemes. Education and Experience: • Bachelor's Degree required. • Bachelor's Degree (Master's preferred) in Science, Engineering or a related field preferred. • A minimum of 7-10 years Food Safety/Quality/Regulatory Compliance program execution. • Proven experience and skills in leading team members, developing careers, empowering team members to operate with a high level of influence and independence, providing functional direction while setting clear goals and expectations, and providing performance feedback to advance individual and team performance. • Must demonstrate thorough technical knowledge of Food Safety, Food Processing, applicable USDA and FDA Regulations, Food Allergens, Crisis Management, Food Fraud, Specification Development, Quality Standards, Quality Systems, Sanitary design and Environmental Monitoring, Good Manufacturing Practices (GMP), HACCP and GFSI Certification schemes. • Or, a combination of education and experience providing equivalent knowledge. Physical Requirements: • Work may be performed in an office, remote office or a combination of both where a computer and other office equipment may be used as needed to perform duties. • Regularly required to sit, reach, grasp, stand and move from one area to another. • Constantly and repeatedly use keyboard/mouse. • Occasionally required to push, pull, bend, lift and move up to 25 lbs. Travel: . click apply for full job details
Ready to lead an award-winning team? As an ALDI executive, you are responsible for driving and implementing the key initiatives that keep our customers happy and ensure our business model evolves with the needs of the company. Immerse yourself in a culture of collaboration and continuous improvement with our growing and thriving organization. Are you passionate about ensuring top-notch food safety and quality assurance? ALDI, one of America's fastest-growing retailer with an extensive array of private label products, is seeking a dynamic leader to fill the role of Director of Food Safety and Quality Assurance. This is your chance to spearhead the development and implementation of quality strategies that will shape the future of our organization. As the Director, you'll have the opportunity to drive innovation, maintain rigorous standards, and uphold our commitment to excellence in every aspect of our product offerings. Join us and be at the forefront of shaping the food industry landscape while enjoying the satisfaction of ensuring consumer trust and satisfaction. In this role the QA Director will lead the Food Safety and Quality Assurance function by defining, communicating, and coordinating the implementation of the organization's FSQA strategy to ensure that products are safe, legal and meet the quality expectations of our customers. The ideal candidate has extensive knowledge of FDA and USDA regulations and broad knowledge of Food Safety and Quality standards including GFSI, HACCP and Lean Six Sigma. Diverse knowledge of different product manufacturing technologies, ingredients, and methods as well as an educational background in Science or Engineering is preferred. Position Type: Full-Time Work Location: Batavia, IL Duties and Responsibilities: Must be able to perform duties with or without reasonable accommodation. • Leads Quality Assurance, Food Safety and Regulatory Compliance at ALDI and is responsible for planning, developing, and directing all quality assurance, food safety and regulatory policies, programs, and initiatives in accordance with quality and regulatory guidelines and requirements. • Directly accountable for the quality strategy development, implementation, and performance of ALDI Private Label Products. • Reports to leadership on quality performance, incidents, and trends. • Recruits, trains and manages a team of high performing QA staff to drive continuous improvement throughout the organization using comprehensive risk assessment, clear goals and expectations, and a focus on data analysis to identify strategic opportunities for improvement. • Recruits, relocates, and recommends qualified employees for their team; determines the appropriate training methods/courses for new hires. • Determines the salary levels for newly-hired or transferred employees reporting to them according to the established company wage structure. • Understands the overarching company strategy, while communicating and modeling the core values of the organization to create a sense of teamwork and membership among employees. • Establishes, communicates and evaluates job responsibilities and performance expectations to their team to ensure mutual understanding of desired results. • Liaises with authorities as required and serves as communication liaison between department managers and upper management to assure understanding of goals, objectives, and opportunities for improvement. • Performs root-cause analysis and other problem solving activities in order to identify and recommend effective corrective actions and process improvements. • Reports to leadership on quality issues, trends, and losses. • Establishes and communicates procedures and standards with departments in their areas of responsibility. • Oversees the appropriate resolution of serious customer concerns. • Recommends actions based on identified trends from customer feedback. • Consults with executives on the development of their team's strategy. • Makes recommendations to executives on how to improve, design, and streamline applicable policies, procedures, and practices. • Manages external consultants accordingly. • Liaises with directors in other ALDI countries to facilitate the sharing of best practices. • Manages and communicates ALDI protocol with testing agencies and third party auditors. • Keeps up to date with all legal requirements in areas of responsibility. • Contributes to the International QA Steering Committee and participates in working groups as required. • Ensures appropriate processes are implemented to verify ALDI Private Label products are safe, legal and meeting the quality expectations of our customers. • Directs their team by ensuring that all projects and tasks meet business needs as well as expectations for quality and service. • Establishes team objectives that align with the overall company strategy. • Participates in National and Specialist Committees as required to establish best practice and business consistency. • Identifies and develops company-wide and individual initiatives for their team. • Complies with ALDI privacy and security requirements and policies if job responsibilities include possible access to confidential and/or sensitive information. • Other duties as assigned. Job-specific Competencies: Knowledge/Skills/Abilities • Consistently demonstrates the ALDI Acts Competencies as outlined for the role. • Extensive working knowledge of HACCP, HARPC, FSMA, FSVP and GFSI. • Diverse knowledge of inspection and control methods, techniques, and documentation. • Ability to read, analyze, and interpret common scientific and technical journals, regulatory reports and legal documents. • Ability to accurately assess risk and provide sound organizational recommendations that incorporate quality and regulatory guidelines and reflect the needs of the business. • Ability to effectively collaborate with the company executive team and senior leadership at suppliers and third-party partners. • Working knowledge of product formulations, development, scale-up, mass production and quality control activities. • Skilled at performing root-cause analysis and other problem-solving activities to identify effective corrective action and process improvements. • Excellent communication skills (written and verbal). • Strong computer skills including quality control applications, word processing, spreadsheets and databases as may be required Gives attention to detail and follows instruction. • Understands the history, strategy, organizational authority, interdependence of job duties, products, systems and services of the company. • Ability to develop rapport, trust and open communication that enhances the growth and job performance of direct reports. • Understands cost/benefit analysis. • Ability to recommend, interpret, and/or apply company policies and procedures. • Knowledge of products and services of the company. • Understands, recognizes, and effectively manages challenges by proactively working to decrease their impact and frequency. • Knowledge of accepted industry standards and practices. • Ability to thrive in a fast-paced work environment, consistently meeting deadlines and remaining calm under pressure. • Extensive working knowledge of HACCP, HARPC, FSMA, FSVP and GFSI. • Knowledge of inspection and control methods, techniques, and documentation. • Ability to read, analyze, and interpret common scientific and technical journals, regulatory reports and legal documents. • Ability to accurately assess risk and provide sound organizational recommendations that incorporate quality and regulatory guidelines and reflect the needs of the business. • Knowledge of product formulations, development, scale-up, mass production and quality control activities. • Strong computer skills including quality control applications, word processing, spreadsheets and databases. • Knowledge of Food Safety, Food Processing, applicable USDA and FDA Regulations, Food Allergens, Crisis Management, Food Fraud, Specification Development, Quality Standards, Quality Systems, Sanitary design and Environmental Monitoring, Good Manufacturing Practices, HACCP and GFSI Certification schemes. Education and Experience: • Bachelor's Degree required. • Bachelor's Degree (Master's preferred) in Science, Engineering or a related field preferred. • A minimum of 7-10 years Food Safety/Quality/Regulatory Compliance program execution. • Proven experience and skills in leading team members, developing careers, empowering team members to operate with a high level of influence and independence, providing functional direction while setting clear goals and expectations, and providing performance feedback to advance individual and team performance. • Must demonstrate thorough technical knowledge of Food Safety, Food Processing, applicable USDA and FDA Regulations, Food Allergens, Crisis Management, Food Fraud, Specification Development, Quality Standards, Quality Systems, Sanitary design and Environmental Monitoring, Good Manufacturing Practices (GMP), HACCP and GFSI Certification schemes. • Or, a combination of education and experience providing equivalent knowledge. Physical Requirements: • Work may be performed in an office, remote office or a combination of both where a computer and other office equipment may be used as needed to perform duties. • Regularly required to sit, reach, grasp, stand and move from one area to another. • Constantly and repeatedly use keyboard/mouse. • Occasionally required to push, pull, bend, lift and move up to 25 lbs. Travel: . click apply for full job details
Eli Lilly and Company
Durham, North Carolina
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Description: Senior Principal Associate - QA Site Compliance serves as the site inspection readiness steward to lead the inspection readiness program at the RTP site. The inspection readiness steward will have oversight of the inspection readiness program and processes and provide quality auditing expertise in regulation requirements for all aspects of manufacturing conducted at RTP. Key Objectives/Deliverables: Coordinates and manages regulatory inspections including logistics and data system(s). Implement and Lead the site inspection readiness program Implement and Lead the Quality Oversight program Acts as data steward and trainer for site audit data system(s) Leads inspection readiness huddles Monitor and report on the status and effectiveness of the inspection readiness program and needed improvements Perform local site impact assessments in response to Lilly site external inspection findings and external trendings in accordance with Lilly's regulatory change management program. Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization Leads site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation Serve as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for individual contributors and management at the site Lead and model behaviors foundational to strong quality culture Performs site self-inspections, as necessary Support site safety initiatives. Basic Requirements: BSc or MSc in scientific/technical discipline: chemistry, biology, microbiology, engineering or equivalent scientific/technical degree 10+ years of experience in pharmaceutical and/or medical device industry Preferred attributes but not required: Extensive knowledge of external Regulations and Lilly Quality System requirements Ability to function in a team environment as a leader and as a team member Demonstrated ability to partner/network with other sites Demonstrated participations in inspections and inspection readiness activities including acting as an audit host. Demonstrated ability to manage projects. Proficiency with computer systems. Multi product facility knowledge including parenteral drug product manufacturing, device assembly and packaging activities Good knowledge of cGMPs, ISO and quality management systems with demonstrated technical proficiency Strong communication and interpersonal skills with ability to influence multiple levels of the organization Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environment. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals Additional Information: US/OUS travel may be required Flex hours possible Site operates 24/7 - overtime may be required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Position Description: Senior Principal Associate - QA Site Compliance serves as the site inspection readiness steward to lead the inspection readiness program at the RTP site. The inspection readiness steward will have oversight of the inspection readiness program and processes and provide quality auditing expertise in regulation requirements for all aspects of manufacturing conducted at RTP. Key Objectives/Deliverables: Coordinates and manages regulatory inspections including logistics and data system(s). Implement and Lead the site inspection readiness program Implement and Lead the Quality Oversight program Acts as data steward and trainer for site audit data system(s) Leads inspection readiness huddles Monitor and report on the status and effectiveness of the inspection readiness program and needed improvements Perform local site impact assessments in response to Lilly site external inspection findings and external trendings in accordance with Lilly's regulatory change management program. Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization Leads site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation Serve as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for individual contributors and management at the site Lead and model behaviors foundational to strong quality culture Performs site self-inspections, as necessary Support site safety initiatives. Basic Requirements: BSc or MSc in scientific/technical discipline: chemistry, biology, microbiology, engineering or equivalent scientific/technical degree 10+ years of experience in pharmaceutical and/or medical device industry Preferred attributes but not required: Extensive knowledge of external Regulations and Lilly Quality System requirements Ability to function in a team environment as a leader and as a team member Demonstrated ability to partner/network with other sites Demonstrated participations in inspections and inspection readiness activities including acting as an audit host. Demonstrated ability to manage projects. Proficiency with computer systems. Multi product facility knowledge including parenteral drug product manufacturing, device assembly and packaging activities Good knowledge of cGMPs, ISO and quality management systems with demonstrated technical proficiency Strong communication and interpersonal skills with ability to influence multiple levels of the organization Strong self-management and organizational skills, ability to prioritize, critical decision-making skills, problem solving, mentorship and coaching skills. Self-motivation, lead the way for ensuring a fair and equitable work environment. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals Additional Information: US/OUS travel may be required Flex hours possible Site operates 24/7 - overtime may be required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
Eli Lilly and Company
Durham, North Carolina
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up. The Sterility Assurance Steward- Technical Services / Manufacturing Science (TS/MS) is a role encompasses technical leadership and advisory roles in all aspects of sterility assurance of parenteral products, including but not limited to formulation, container closure, delivery systems, processing and manufacturing environment. The Sterility Assurance Steward develops and implements a technical agenda with three primary objectives: (1) reliable, compliant manufacturing of the drug product; (2) improvement of the process control strategy, continuous optimization, development and the innovation of technologies; (3) continual deepening of the scientific understanding of sterility assurance. The technical agenda exists throughout the entire product, process and facility lifecycle. A key attribute of this position includes assessment of existing strategies to identify areas for continuous improvement and development of new strategies for sterility assurance programs, including Contamination Control Strategy, Aseptic Process Simulation, Filter Validation, Container Closure Validation, Leaks and Glove Management, Environmental Monitoring, Facility Disinfection, Gowning and Hygiene, and Sterility Assurance Risk Management programs. At the Steward level, the scientist provides leadership and influence across the Parenteral Network. The scope of the role includes syringe filling and device assembly & packaging operations for commercially manufactured products targeted for transfer to the RTP site. Key Objectives / Deliverables: Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. Use sterility assurance risk management to evaluate existing and proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination. Lead and / or participate in complex projects associated with sterility assurance programs. Lead and / or assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.) Lead major deviations for root cause analysis related to sterility assurance programs. Remain abreast of external regulatory requirements associated with sterility assurance programs. Influence revision to corporate guidance associated with sterility assurance programs. Identify and implement continuous improvement for sterility assurance programs. Provide design input related to new processes (e.g., facilities, equipment, etc.) for RTP. Represents and defends the site's sterility assurance programs during internal audits and external regulatory inspections. Assists with writing of regulatory submissions for sterility assurance programs. Create, review, approve and provide sterility assurance training for new hires and personnel from other sites. Provide technical mentorship to a less senior scientists within the TS/MS organization. Provide technical mentorship to a less senior cross-functional personnel within RTP. Provide technical consultation across the Parenteral Network. Minimum Requirements: BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline Minimum 10 years' experience in the biopharmaceutical industry Additional Preferences: Masters Degree in Microbiology, Biology or related scientific field (or equivalent work experience) preferred Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.) In depth knowledge of risk management and the understanding / ability to use risk assessment tools Ability to analyze complex data and solve problems Strong technical writing and presentation skills Teamwork / interpersonal skills ability to effectively influence Knowledge of microbiology and sterility assurance Other Information: Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required. Position will be based out of RTP site with ability to travel to Indianapolis and other global Lilly sites as required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up. The Sterility Assurance Steward- Technical Services / Manufacturing Science (TS/MS) is a role encompasses technical leadership and advisory roles in all aspects of sterility assurance of parenteral products, including but not limited to formulation, container closure, delivery systems, processing and manufacturing environment. The Sterility Assurance Steward develops and implements a technical agenda with three primary objectives: (1) reliable, compliant manufacturing of the drug product; (2) improvement of the process control strategy, continuous optimization, development and the innovation of technologies; (3) continual deepening of the scientific understanding of sterility assurance. The technical agenda exists throughout the entire product, process and facility lifecycle. A key attribute of this position includes assessment of existing strategies to identify areas for continuous improvement and development of new strategies for sterility assurance programs, including Contamination Control Strategy, Aseptic Process Simulation, Filter Validation, Container Closure Validation, Leaks and Glove Management, Environmental Monitoring, Facility Disinfection, Gowning and Hygiene, and Sterility Assurance Risk Management programs. At the Steward level, the scientist provides leadership and influence across the Parenteral Network. The scope of the role includes syringe filling and device assembly & packaging operations for commercially manufactured products targeted for transfer to the RTP site. Key Objectives / Deliverables: Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals. Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems. Use sterility assurance risk management to evaluate existing and proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination. Lead and / or participate in complex projects associated with sterility assurance programs. Lead and / or assist in the development and execution of process and facility monitoring strategies that focus on areas of highest microbial risk (e.g., disinfectant/sanitizing agent evaluation, resident microflora evaluation, airflow pattern testing, environmental monitoring PQ, aseptic process simulations, etc.) Lead major deviations for root cause analysis related to sterility assurance programs. Remain abreast of external regulatory requirements associated with sterility assurance programs. Influence revision to corporate guidance associated with sterility assurance programs. Identify and implement continuous improvement for sterility assurance programs. Provide design input related to new processes (e.g., facilities, equipment, etc.) for RTP. Represents and defends the site's sterility assurance programs during internal audits and external regulatory inspections. Assists with writing of regulatory submissions for sterility assurance programs. Create, review, approve and provide sterility assurance training for new hires and personnel from other sites. Provide technical mentorship to a less senior scientists within the TS/MS organization. Provide technical mentorship to a less senior cross-functional personnel within RTP. Provide technical consultation across the Parenteral Network. Minimum Requirements: BS or MS in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, or other related scientific discipline Minimum 10 years' experience in the biopharmaceutical industry Additional Preferences: Masters Degree in Microbiology, Biology or related scientific field (or equivalent work experience) preferred Facility start-up and/or technical transfer experience, including environmental monitoring performance qualification and aseptic process simulations Prior experience in multiple functions associated with manufacture of parenteral products (e.g. operations, environmental monitoring, sterility assurance validation, microbiology laboratory, technical services, quality assurance, etc.) In depth knowledge of risk management and the understanding / ability to use risk assessment tools Ability to analyze complex data and solve problems Strong technical writing and presentation skills Teamwork / interpersonal skills ability to effectively influence Knowledge of microbiology and sterility assurance Other Information: Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required. Position will be based out of RTP site with ability to travel to Indianapolis and other global Lilly sites as required Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.