Eli Lilly and Company
Sr. Director – Quality – Small Molecule API External Manufacturing
Eli Lilly and Company, Indiana, Pennsylvania, us, 15705
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.
Position Brand Description API External Manufacturing (API EM) supports the delivery of Lilly medicines by providing oversight of the manufacturing of Small Molecules, Large Molecule and Peptide APIs at external manufacturing facilities globally.
The Sr. Director – Quality – Small Molecule API EM is the Site Quality Leader for the Small Molecule Plant within the API EM organization and is responsible for all quality activities related to the oversight of Small Molecule APIs for commercial products. They ensure that products are manufactured, tested and released in accordance with marketing authorization requirements and cGMPs and drive continuous improvement to adapt to the business requirements. This role stays abreast of changing internal and external regulatory expectations to focus on continuous improvement and evolving priorities.
Key Responsibilities
Site Quality Leader for Small Molecule Plant: ensure products are manufactured and released in compliance with marketing authorizations and GMPs.
Lead the definition of the quality strategy and quality plans for the Small Molecule Plant and align with Site Quality leaders from Large Molecule and Peptide Plants and the broader External Manufacturing organization.
Ensure the Small Molecule Plant operates in accordance with the quality management system for API External Manufacturing.
Ensure staff are qualified and that required training of all quality personnel is completed and adapted as needed.
Develop and maintain robust control strategies for the API EM Small Molecule portfolio.
Maintain robust batch release execution processes and evaluate batch production records.
Provide appropriate oversight of Contract Manufacturers and Contract Laboratories and ensure they have effective quality systems in place.
Support Inspection activities at Contract Manufacturers and Contract Laboratories as required.
Ensure all required testing is conducted compliantly, including setting specifications, robust sampling processes and investigating anomalies.
Ensure the site quality system is effective, including execution of the site self-inspection program.
Investigate and resolve deviations, OOS and complaints.
Ensure available stability data to support storage, retest or expiration dating periods.
Participate in and approve annual product reviews.
Notify senior management of significant quality-related issues.
Ensure prompt closure of all regulatory commitments.
Member of Small Molecule Plant Lead Team As a member of the Small Molecule Plant Lead Team, the Sr. Director – Quality – Small Molecule External Manufacturing API shares responsibilities with the Operations Leader as follows:
Ensure and monitor compliance with local regulations and GMP requirements.
Authorize written procedures and other key GMP documents.
Participate in management reviews of process performance, product and data quality, and the quality management system, advocating continual improvement.
Ensure timely and effective communication and escalation of quality issues to appropriate management levels.
Ensure the adequacy and effectiveness of the personnel qualification and training program.
Approve and monitor suppliers of material (where owned by Lilly).
Approve and monitor contract manufacturers, GMP service providers, and consultants.
Ensure robust record retention processes for the Small Molecule Plant.
Key Objectives/Deliverables
Serve as the Site Quality Leader for the Small Molecule EM Plant as a member of the Small Molecule API EM Plant Lead Team.
Ensure site compliance to all cGMPs, procedures, standards, guidelines and regulatory commitments.
Support quality-related forums required to maintain compliance and continuous improvements.
Ensure creation and maintenance of a site Quality Plan and monitoring of metrics to deliver a compliant quality system.
Coordinate and oversee regulatory inspections.
Review and approve documents supporting manufacturing and quality systems (e.g., procedures, deviations, changes).
Build strong relationships with peers in API EM management, internal customers/partners, and CM partners.
Lead organizational and business planning for the Small Molecule Quality organization, ensuring adequate QA resources and future readiness.
Lead the API EM Quality team, including coaching, performance management, mentoring, and succession planning.
Participate on the External Manufacturing Quality Leadership team, establishing strategies and processes for working with contract manufacturers and laboratories.
Establish and improve interfaces between contract manufacturers and Lilly’s quality systems via day-to-day interactions and Quality Agreements.
Basic Requirements
BS or equivalent in a scientific field or engineering.
At least 10 years of experience in Quality, Technical Services, Operations, Engineering or Regulatory supporting pharmaceutical manufacturing.
Experience leading teams.
Additional Preferences
Excellent interpersonal and networking skills.
Strong written and verbal communications skills.
Ability to organize and prioritize multiple tasks.
Proven problem solving and analytical thinking skills.
Understanding of statistical tools and analysis.
Experience overseeing work at Contract Manufacturers/Laboratories.
Experience leading leaders.
Ability to influence diverse groups.
Educational Requirements
BS or equivalent in a scientific field or engineering.
Other Information
Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
Must carry a cell phone to support 24 hour/day operations.
Global travel is needed (approximately 25%).
Extended work hours may be required during regulatory inspections, critical production issues, or to interact with staff working on various shifts.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form at https://careers.lilly.com/us/en/workplace-accommodation for further assistance. This is for individuals to request an accommodation as part of the application process; other correspondence will not receive a response.
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.
Our employee resource groups (ERGs) offer strong support networks and are open to all employees. Groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $156,000 - $228,800. Full-time employees are eligible for a company bonus (dependent on company and individual performance). Lilly offers a comprehensive benefits program including eligibility for a 401(k), pension, vacation benefits, medical/dental/vision benefits, flexible spending accounts, life insurance, leave benefits, and well-being programs. Lilly reserves the right to amend compensation and benefits programs at its discretion.
#WeAreLilly
#J-18808-Ljbffr
Position Brand Description API External Manufacturing (API EM) supports the delivery of Lilly medicines by providing oversight of the manufacturing of Small Molecules, Large Molecule and Peptide APIs at external manufacturing facilities globally.
The Sr. Director – Quality – Small Molecule API EM is the Site Quality Leader for the Small Molecule Plant within the API EM organization and is responsible for all quality activities related to the oversight of Small Molecule APIs for commercial products. They ensure that products are manufactured, tested and released in accordance with marketing authorization requirements and cGMPs and drive continuous improvement to adapt to the business requirements. This role stays abreast of changing internal and external regulatory expectations to focus on continuous improvement and evolving priorities.
Key Responsibilities
Site Quality Leader for Small Molecule Plant: ensure products are manufactured and released in compliance with marketing authorizations and GMPs.
Lead the definition of the quality strategy and quality plans for the Small Molecule Plant and align with Site Quality leaders from Large Molecule and Peptide Plants and the broader External Manufacturing organization.
Ensure the Small Molecule Plant operates in accordance with the quality management system for API External Manufacturing.
Ensure staff are qualified and that required training of all quality personnel is completed and adapted as needed.
Develop and maintain robust control strategies for the API EM Small Molecule portfolio.
Maintain robust batch release execution processes and evaluate batch production records.
Provide appropriate oversight of Contract Manufacturers and Contract Laboratories and ensure they have effective quality systems in place.
Support Inspection activities at Contract Manufacturers and Contract Laboratories as required.
Ensure all required testing is conducted compliantly, including setting specifications, robust sampling processes and investigating anomalies.
Ensure the site quality system is effective, including execution of the site self-inspection program.
Investigate and resolve deviations, OOS and complaints.
Ensure available stability data to support storage, retest or expiration dating periods.
Participate in and approve annual product reviews.
Notify senior management of significant quality-related issues.
Ensure prompt closure of all regulatory commitments.
Member of Small Molecule Plant Lead Team As a member of the Small Molecule Plant Lead Team, the Sr. Director – Quality – Small Molecule External Manufacturing API shares responsibilities with the Operations Leader as follows:
Ensure and monitor compliance with local regulations and GMP requirements.
Authorize written procedures and other key GMP documents.
Participate in management reviews of process performance, product and data quality, and the quality management system, advocating continual improvement.
Ensure timely and effective communication and escalation of quality issues to appropriate management levels.
Ensure the adequacy and effectiveness of the personnel qualification and training program.
Approve and monitor suppliers of material (where owned by Lilly).
Approve and monitor contract manufacturers, GMP service providers, and consultants.
Ensure robust record retention processes for the Small Molecule Plant.
Key Objectives/Deliverables
Serve as the Site Quality Leader for the Small Molecule EM Plant as a member of the Small Molecule API EM Plant Lead Team.
Ensure site compliance to all cGMPs, procedures, standards, guidelines and regulatory commitments.
Support quality-related forums required to maintain compliance and continuous improvements.
Ensure creation and maintenance of a site Quality Plan and monitoring of metrics to deliver a compliant quality system.
Coordinate and oversee regulatory inspections.
Review and approve documents supporting manufacturing and quality systems (e.g., procedures, deviations, changes).
Build strong relationships with peers in API EM management, internal customers/partners, and CM partners.
Lead organizational and business planning for the Small Molecule Quality organization, ensuring adequate QA resources and future readiness.
Lead the API EM Quality team, including coaching, performance management, mentoring, and succession planning.
Participate on the External Manufacturing Quality Leadership team, establishing strategies and processes for working with contract manufacturers and laboratories.
Establish and improve interfaces between contract manufacturers and Lilly’s quality systems via day-to-day interactions and Quality Agreements.
Basic Requirements
BS or equivalent in a scientific field or engineering.
At least 10 years of experience in Quality, Technical Services, Operations, Engineering or Regulatory supporting pharmaceutical manufacturing.
Experience leading teams.
Additional Preferences
Excellent interpersonal and networking skills.
Strong written and verbal communications skills.
Ability to organize and prioritize multiple tasks.
Proven problem solving and analytical thinking skills.
Understanding of statistical tools and analysis.
Experience overseeing work at Contract Manufacturers/Laboratories.
Experience leading leaders.
Ability to influence diverse groups.
Educational Requirements
BS or equivalent in a scientific field or engineering.
Other Information
Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
Must carry a cell phone to support 24 hour/day operations.
Global travel is needed (approximately 25%).
Extended work hours may be required during regulatory inspections, critical production issues, or to interact with staff working on various shifts.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form at https://careers.lilly.com/us/en/workplace-accommodation for further assistance. This is for individuals to request an accommodation as part of the application process; other correspondence will not receive a response.
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.
Our employee resource groups (ERGs) offer strong support networks and are open to all employees. Groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $156,000 - $228,800. Full-time employees are eligible for a company bonus (dependent on company and individual performance). Lilly offers a comprehensive benefits program including eligibility for a 401(k), pension, vacation benefits, medical/dental/vision benefits, flexible spending accounts, life insurance, leave benefits, and well-being programs. Lilly reserves the right to amend compensation and benefits programs at its discretion.
#WeAreLilly
#J-18808-Ljbffr