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.
Apr 09, 2024
Full time
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.
Summary: White Lodging develops and operates a portfolio of award-winning, premium-brand hotels, rooftop bars and restaurants in some of the country's best cities to live. We know that the hospitality business, like life, is how you make people feel. That's where you come in. You'll help bring the virtue of hospitality to life while we create an environment that allows you to be your best self and grow. Responsibilities What You'll Do Chef is responsible for all culinary operations within the hotel or outlet including the execution of recipes, financial profitability, staffing, usage of White Lodging SOPs, and compliance with local and Federal guidelines. Be a highly valued and hands-on Subject Matter Expert for the culinary team regarding safe and delicious food handling, preparation, and presentation. Lead, coach, mentor and develop all associates to maintain high engagement, a high internal promotion rate and low turnover within the department while executing the White Lodging Way FOH & BOH Systems Foster a productive relationship with Sales & Marketing, Event Management, FOH team, and other departments within the hotel, owners, business partners and vendors. Facilitate the ordering, preparing, marketing, and executing of all recipes and USE Records, all costs associated with the profitability of the culinary department. Actively participate in property specific month/year end processes and reporting. What You'll Bring The Executive Chef will have strong interpersonal and communication skills to lead and develop their team. The natural inclination to problem solve complex issues and come to creative solutions. High proficiency in culinary financial management, menu creation, attention to detail, leading others, and using a hands-on approach to all systems and processes. Strong observational skills, responsibility, accountability and walk-through techniques - gauging quantity and quality levels of food, service readiness and execution, inventory levels, cleanliness, safety and sanitation etc. Other Information Day 1 Medical, Dental and Vision insurance Vacation/Paid Time Off (PTO) with rollover Complimentary wellness tools Unlimited referral bonuses 401(k) with company match Hostcare Resources healthcare concierge Leadership development Tuition reimbursement Discounts on hotel rooms, dining, and other travel/entertainment experiences Multiple hotels in each market = more opportunities White Lodging is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all associates. Compensation starts at $80,000.00 per year Location Code: 2554
Apr 09, 2024
Full time
Summary: White Lodging develops and operates a portfolio of award-winning, premium-brand hotels, rooftop bars and restaurants in some of the country's best cities to live. We know that the hospitality business, like life, is how you make people feel. That's where you come in. You'll help bring the virtue of hospitality to life while we create an environment that allows you to be your best self and grow. Responsibilities What You'll Do Chef is responsible for all culinary operations within the hotel or outlet including the execution of recipes, financial profitability, staffing, usage of White Lodging SOPs, and compliance with local and Federal guidelines. Be a highly valued and hands-on Subject Matter Expert for the culinary team regarding safe and delicious food handling, preparation, and presentation. Lead, coach, mentor and develop all associates to maintain high engagement, a high internal promotion rate and low turnover within the department while executing the White Lodging Way FOH & BOH Systems Foster a productive relationship with Sales & Marketing, Event Management, FOH team, and other departments within the hotel, owners, business partners and vendors. Facilitate the ordering, preparing, marketing, and executing of all recipes and USE Records, all costs associated with the profitability of the culinary department. Actively participate in property specific month/year end processes and reporting. What You'll Bring The Executive Chef will have strong interpersonal and communication skills to lead and develop their team. The natural inclination to problem solve complex issues and come to creative solutions. High proficiency in culinary financial management, menu creation, attention to detail, leading others, and using a hands-on approach to all systems and processes. Strong observational skills, responsibility, accountability and walk-through techniques - gauging quantity and quality levels of food, service readiness and execution, inventory levels, cleanliness, safety and sanitation etc. Other Information Day 1 Medical, Dental and Vision insurance Vacation/Paid Time Off (PTO) with rollover Complimentary wellness tools Unlimited referral bonuses 401(k) with company match Hostcare Resources healthcare concierge Leadership development Tuition reimbursement Discounts on hotel rooms, dining, and other travel/entertainment experiences Multiple hotels in each market = more opportunities White Lodging is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all associates. Compensation starts at $80,000.00 per year Location Code: 2554
Summary: White Lodging develops and operates a portfolio of award-winning, premium-brand hotels, rooftop bars and restaurants in some of the country's best cities to live. We know that the hospitality business, like life, is how you make people feel. That's where you come in. You'll help bring the virtue of hospitality to life while we create an environment that allows you to be your best self and grow. Responsibilities What You'll Do Chef is responsible for all culinary operations within the hotel or outlet including the execution of recipes, financial profitability, staffing, usage of White Lodging SOPs, and compliance with local and Federal guidelines. Be a highly valued and hands-on Subject Matter Expert for the culinary team regarding safe and delicious food handling, preparation, and presentation. Lead, coach, mentor and develop all associates to maintain high engagement, a high internal promotion rate and low turnover within the department while executing the White Lodging Way FOH & BOH Systems Foster a productive relationship with Sales & Marketing, Event Management, FOH team, and other departments within the hotel, owners, business partners and vendors. Facilitate the ordering, preparing, marketing, and executing of all recipes and USE Records, all costs associated with the profitability of the culinary department. Actively participate in property specific month/year end processes and reporting. What You'll Bring The Executive Chef will have strong interpersonal and communication skills to lead and develop their team. The natural inclination to problem solve complex issues and come to creative solutions. High proficiency in culinary financial management, menu creation, attention to detail, leading others, and using a hands-on approach to all systems and processes. Strong observational skills, responsibility, accountability and walk-through techniques - gauging quantity and quality levels of food, service readiness and execution, inventory levels, cleanliness, safety and sanitation etc. Other Information Day 1 Medical, Dental and Vision insurance Vacation/Paid Time Off (PTO) with rollover Complimentary wellness tools Unlimited referral bonuses 401(k) with company match Hostcare Resources healthcare concierge Leadership development Tuition reimbursement Discounts on hotel rooms, dining, and other travel/entertainment experiences Multiple hotels in each market = more opportunities White Lodging is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all associates. Compensation starts at $80,000.00 per year Location Code: 2554
Apr 09, 2024
Full time
Summary: White Lodging develops and operates a portfolio of award-winning, premium-brand hotels, rooftop bars and restaurants in some of the country's best cities to live. We know that the hospitality business, like life, is how you make people feel. That's where you come in. You'll help bring the virtue of hospitality to life while we create an environment that allows you to be your best self and grow. Responsibilities What You'll Do Chef is responsible for all culinary operations within the hotel or outlet including the execution of recipes, financial profitability, staffing, usage of White Lodging SOPs, and compliance with local and Federal guidelines. Be a highly valued and hands-on Subject Matter Expert for the culinary team regarding safe and delicious food handling, preparation, and presentation. Lead, coach, mentor and develop all associates to maintain high engagement, a high internal promotion rate and low turnover within the department while executing the White Lodging Way FOH & BOH Systems Foster a productive relationship with Sales & Marketing, Event Management, FOH team, and other departments within the hotel, owners, business partners and vendors. Facilitate the ordering, preparing, marketing, and executing of all recipes and USE Records, all costs associated with the profitability of the culinary department. Actively participate in property specific month/year end processes and reporting. What You'll Bring The Executive Chef will have strong interpersonal and communication skills to lead and develop their team. The natural inclination to problem solve complex issues and come to creative solutions. High proficiency in culinary financial management, menu creation, attention to detail, leading others, and using a hands-on approach to all systems and processes. Strong observational skills, responsibility, accountability and walk-through techniques - gauging quantity and quality levels of food, service readiness and execution, inventory levels, cleanliness, safety and sanitation etc. Other Information Day 1 Medical, Dental and Vision insurance Vacation/Paid Time Off (PTO) with rollover Complimentary wellness tools Unlimited referral bonuses 401(k) with company match Hostcare Resources healthcare concierge Leadership development Tuition reimbursement Discounts on hotel rooms, dining, and other travel/entertainment experiences Multiple hotels in each market = more opportunities White Lodging is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all associates. Compensation starts at $80,000.00 per year Location Code: 2554