Associate Director - Drug Product External Manufacturing QA Batch Release/Ops at Eli Lilly and Company

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:

Drug Product External Manufacturing Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of contract manufacturers and alliance partners. Our team is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.

The QA Operations Associate Director position is responsible of the development, management, and continuous improvement of the DPEM quality system through the Quality Assurance team (QA team). Specifically, the QA Operations Assoicate Director will be responsible for quality activities related to batch release program oversight and maintenance of parenteral products and facilities within the US.

Responsibilities:

Safety:

·       Support implementation of HSE initiatives and ensure safety goals are achieved.

Contract manufactures management:

·       Support Corporate audits, CM´s inspections (as required) and follow up on audit findings, ensuring that DPEM are taking appropriate action in due time.

·       Support identified Contract Manufacturers (CMs), including Joint Process Team Leader (JPT Leader), Flow Teams and Alliance Management processes as required.

·       Support the communication of Lilly Quality requirements to CMs.

·       Review, revise, and support maintenance of Quality Agreements.

Quality Systems:

·       Support the implementation Quality systems and Q initiatives at CM Level.

·       Support QA Representatives to follow appropriate quality systems:  COMTRIX/RIM, TrackWise (for complaints, deviations & change controls).

·       Support DPEM governance processes including Deviation and Change Review Boards, Quality Backlog, Site-Self Inspections, Site Quality Lead Team (SQLT).

·       Support implementation of Global Quality Standards, Lilly Quality Standards, Global Contract Manufacturing Standards, and local SOPs for DPEM.

General:

·       Lead the DPEM US Quality Assurance Batch Release team.

·       Ensure use of Performance Management system for employees in Quality Assurance team, including developing skills and performance of direct reports.

·       Perform notification to management of quality issues as necessary.

·       Respond to requests for data and information from DPEM and CMs.

·       Contribute to Business Plan and Long-Range Plan.

Relationships:

·       As the Lilly representative, develop professional relationships with all relevant personnel at Contract Manufacturers, as appropriate.

Basic Requirements:

Education:

o   Bachelor´s degree in Biology, Chemistry, Pharmacy, Engineering or similar technical background.

Experience:

o   Minimum 5 years of experience in technical and quality functions within a parenteral manufacturing site.

Additional Skills/Preferences:

• Experience with drug product batch release.

• Proven ability to effectively lead a team through competing and changing priorities.

• Proficient in Trackwise, SAP, Veeva.

• Appreciation of cultural diversity.

• Capacity planning, organizational leadership experience.

• Previous leadership experience preferred.

Additional Information:
• Travel up to 20%
• Position location: Lilly Corporate Center, Indianapolis IN

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