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:
Lilly’s API External Manufacturing (API EM) provides oversight for all outsourced drug substance manufacturing operations for Lilly across multiple technical platforms. API EM personnel are primarily based in Indianapolis, IN, USA and Kinsale, Ireland. API EM ensures that safe, high quality drug substance is produced at contract manufacturers to meet the needs of the patients we serve, to provide uninterrupted supply of commercial products and delivery of key portfolio programs across diverse disease states.
Responsibilities:
The API External Manufacturing (API EM) QA Associate Director ensures that API EM operations have robust quality oversight. The API EM QA Associate Director is responsible for quality projects supporting API EM, the productivity and development of the QA employees, and the quality of the large molecule and peptide intermediate products manufactured by the Contract Manufacturers (CM). The API EM QA Associate Director ensures the quality systems of the CM meet Lilly quality standards and CGMPs and are compliant with Quality Agreement(s). The Associate Director will oversee the department’s performance, resolution of quality issues, and compliance.

Key Deliverables:

• Make decisions regarding the quality of batches, resolution of quality issues and quality performance for partners. This role will have responsibility for API EM’s portfolio of monoclonal antibodies, microbially expressed products, and peptide intermediates.
• Lead the API EM QA team, providing coaching/feedback to develop QA employees, including performance management, talent assessments, mentoring, succession planning, and organizational planning.
• Build working relationships with API EM management, key internal customers/partners, and strengthen CM alliances.
• Establish and improve business processes to provide any necessary interface between the CM’s and Lilly’s quality systems (e.g., deviations, complaints, change management) via day-to-day interactions and maintaining Quality Agreements.
• Support API EM’ s efforts to maintain and improve our quality systems and ensure alignment with Lilly Global Quality Standards and regulatory agency expectations.
• Coordinate quality activities for outsourcing of Lilly’s targeted projects to CMs, including maintaining Risk-Based Oversight practices.
• Support regulatory agency inspections at the CM, provide management status updates and participate in the resolution of regulatory findings by coordinating CM and Lilly responses.

Basic Requirements:

• Demonstrated knowledge of CGMPs.
• Prior Experience in Manufacturing, QC, QA, Manufacturing Science & Technology, Engineering and/or Regulatory Affairs.
• Demonstrated strong written and verbal communications skills.
• Strong attention to detail.
• Understanding of statistical tools and analysis.
• Excellent interpersonal skills and networking skills.
• Ability to organize and prioritize multiple tasks.
• Demonstrated strong problem solving and analytical thinking skills.
• Ability to influence diverse groups.
• BS in a science-related field, engineering or equivalent experience.

Additional Skills/Preferences:

• Preferred experience in monoclonal antibodies, microbially expressed products, and/or peptide intermediates.
• Previous experience supervising/leading people.
• Demonstrated understanding of computer applications.

Additional Information:

• Must complete ITP for API EM Quality Assurance Associate Director.
• Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE.
• 24 hour/day operations support may be required.
• Travel is required. (up to 20%)

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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly 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.

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