BioSpace
Associate Director - Quality Assurance API External Manufacturing
BioSpace, Indianapolis, Indiana, us, 46262
Associate Director - Quality Assurance API External Manufacturing
Associate Director - Quality Assurance API External Manufacturing
role at
BioSpace Overview
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. We are seeking a leader to manage QA activities supporting externally manufactured peptides and intermediates, ensure compliance with cGMPs, and maintain alignment with Lilly Global Quality Standards and regulatory expectations. Responsibilities
Make decisions regarding the quality of batches, resolution of quality issues, and quality performance for external partners. Lead the API EM QA team, providing coaching, performance management, mentoring, and succession planning. Build working relationships with API EM management, internal customers, and CM partners to strengthen alliances. Establish and improve interfaces between CM quality systems and Lilly's quality systems (deviations, complaints, change management) via day-to-day interactions and maintaining Quality Agreements. Support efforts to maintain and improve quality systems and ensure alignment with Lilly Global Quality Standards and regulatory expectations. Coordinate quality activities for outsourcing projects to CMs and maintain compliant oversight practices. Support regulatory inspections at the CM, provide status updates, and coordinate CM and Lilly responses to findings. Ensure effective oversight of investigations and complaints. Collaborate globally to share best practices and harmonize quality approaches across sites. Basic Qualifications
Bachelor’s Degree (preferred in Chemistry, Biology, Biotechnology, Pharmacy, or Engineering) 5+ years of experience in pharmaceutical manufacturing or development in areas such as TSMS, Production, Quality Assurance, Quality Control, Engineering, or Regulatory Affairs. Additional Skills/Preferences
Responsible for maintaining a safe work environment Proven leadership, administrative, and organizational skills In-depth knowledge of cGMPs and regulatory expectations Ability to influence and lead diverse groups Ability to address complex regulatory, business, or technical issues within the site and function High attention to detail and a commitment to quality and compliance Ability to build relationships with internal and external customers and partners Strong project management and cross-functional coordination abilities Strong analytical and problem-solving skills with proactive issue identification Effective communication and influence across functional groups Strategic thinking balancing short-term needs with long-term business evolution Flexibility and team-oriented approach Ability to learn and apply technical/scientific knowledge Additional Information
10 – 20% travel may be required Some off-shift work (night/weekend) may be required to support 24/7 operations across global supplier network Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form at Lilly's career site. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Actual compensation will depend on education, experience, skills, and location. The anticipated wage for this position is $118,500 - $173,800. Full-time employees may be eligible for bonuses and a comprehensive benefits program, including 401(k), medical/dental/vision, life insurance, paid time off, and wellness programs. Lilly reserves the right to modify compensation and benefit programs. #WeAreLilly
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Associate Director - Quality Assurance API External Manufacturing
role at
BioSpace Overview
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. We are seeking a leader to manage QA activities supporting externally manufactured peptides and intermediates, ensure compliance with cGMPs, and maintain alignment with Lilly Global Quality Standards and regulatory expectations. Responsibilities
Make decisions regarding the quality of batches, resolution of quality issues, and quality performance for external partners. Lead the API EM QA team, providing coaching, performance management, mentoring, and succession planning. Build working relationships with API EM management, internal customers, and CM partners to strengthen alliances. Establish and improve interfaces between CM quality systems and Lilly's quality systems (deviations, complaints, change management) via day-to-day interactions and maintaining Quality Agreements. Support efforts to maintain and improve quality systems and ensure alignment with Lilly Global Quality Standards and regulatory expectations. Coordinate quality activities for outsourcing projects to CMs and maintain compliant oversight practices. Support regulatory inspections at the CM, provide status updates, and coordinate CM and Lilly responses to findings. Ensure effective oversight of investigations and complaints. Collaborate globally to share best practices and harmonize quality approaches across sites. Basic Qualifications
Bachelor’s Degree (preferred in Chemistry, Biology, Biotechnology, Pharmacy, or Engineering) 5+ years of experience in pharmaceutical manufacturing or development in areas such as TSMS, Production, Quality Assurance, Quality Control, Engineering, or Regulatory Affairs. Additional Skills/Preferences
Responsible for maintaining a safe work environment Proven leadership, administrative, and organizational skills In-depth knowledge of cGMPs and regulatory expectations Ability to influence and lead diverse groups Ability to address complex regulatory, business, or technical issues within the site and function High attention to detail and a commitment to quality and compliance Ability to build relationships with internal and external customers and partners Strong project management and cross-functional coordination abilities Strong analytical and problem-solving skills with proactive issue identification Effective communication and influence across functional groups Strategic thinking balancing short-term needs with long-term business evolution Flexibility and team-oriented approach Ability to learn and apply technical/scientific knowledge Additional Information
10 – 20% travel may be required Some off-shift work (night/weekend) may be required to support 24/7 operations across global supplier network Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form at Lilly's career site. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Actual compensation will depend on education, experience, skills, and location. The anticipated wage for this position is $118,500 - $173,800. Full-time employees may be eligible for bonuses and a comprehensive benefits program, including 401(k), medical/dental/vision, life insurance, paid time off, and wellness programs. Lilly reserves the right to modify compensation and benefit programs. #WeAreLilly
#J-18808-Ljbffr