Associate Director, API Supplier Quality Management

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.

The Manager of Precursor and Supplier Management leads quality oversight of the precursor (API) manufacturing program supporting the production of PET and Radioligand radiopharmaceutical drug products. This role ensures the effective management and routine quality oversight of contracted manufacturers, service providers and related suppliers and vendors of materials and components. This position also provides operational support of commercial QC laboratories.

The integral role collaborates with CMC Contract Manufacturing, Supply Chain, Global Investigational Product and Commercial Quality Assurance, and external contract manufacturers to qualify and manage manufacture of precursor (API) materials. The position is accountable for establishing and maintaining standard operating procedures and quality agreements in alignment with corporate quality standards and current GMP expectations. Working with QA management, the individual develops strategies, and solutions to fulfill these responsibilities, continually enhance the quality system, and identify operational efficiencies.

• Leads the qualification and quality oversight of contract manufacturers and associated suppliers and service providers
• Designs and enhances the risk-based precursor program and leads efforts to update established procedures in alignment with Lilly corporate quality standards
• Completes sponsor release and manages quality distribution activities for precursor and reference standard
• Reviews and approves the validation and testing method transfers for precursor and reference standard methods ensuring compliance with ICH and Lilly quality standards
• Collaborates with cross functional team members and external contract manufacturing partners to investigate and resolve manufacturing issues
• Develops, executes and maintains supplier quality agreements
• Coordinates audit scheduling with the global compliance team and serves as an audit team member or facilitator, as required
• Authors precursor section of annual product review and periodic quality management review
• Partners with supplier quality management to support supplier periodic reviews and change notification assessments
• Educates and mentors team members on quality requirements and expectations

• Bachelor’s degree - Preferred in a scientific discipline relevant to drug discovery, development, pharmacy, biology, or chemistry
• Minimum 5 years’ experience in pharmaceutical manufacturing or Quality Assurance. Preferred strong chemistry background in API production.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

• Strong knowledge of commercial and investigational drug product quality management
• Thorough knowledge of applicable regulations, such as global GMP regulations: US, EU, Japan, ICH Q7 along with IPEC, and ISO standards and the ability to interpret and apply them
• Experience with API manufacturing validation and analytical method validation
• Familiarity with writing and revising Quality Agreements
• Proficient in root causes analysis, review and approval of deviations/investigations, quality assessment of CAPA Plans and change controls
• Ability to simplify complex processes/problems and propose alternate solutions
• Quality oversight experience with third party/contract manufacturing
• Demonstrated negotiation and influence skills
• Demonstrated written, and…