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Job Description
Quality Assurance Associate Director: Ensure safe, high-quality drug substance production at contract manufacturers.
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana. We unite caring with discovery to make life better for people around the world.
Our employees 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're looking for people who are determined to make life better for people around the world.
**Job Responsibilities:**
- Ensure that API EM operations have robust quality oversight.
- Manage quality projects supporting API EM and the productivity and development of the QA employees.
- Oversee the quality of large molecule and peptide intermediate products manufactured by the Contract Manufacturers (CM).
- Ensure compliance with Lilly quality standards and CGMPs.
- Resolve quality issues and oversee department performance.
**Key Deliverables:**
- Make decisions regarding the quality of batches, resolution of quality issues and quality performance for partners.
- Lead the API EM QA team, providing coaching and feedback to develop QA employees.
- Build working relationships with API EM management and strengthen CM alliances.
- Establish and improve business processes between the CM's and Lilly's quality systems.
- Support API EM's efforts to maintain and improve quality systems.
- Coordinate quality activities for outsourcing of Lilly's targeted projects to CMs.
- Support regulatory agency inspections at the CM and participate in the resolution of regulatory findings.
**Requirements:**
- Demonstrated knowledge of CGMPs.
- Prior experience in Manufacturing, QC, QA, Manufacturing Science & Technology, Engineering, and/or Regulatory Affairs.
- Strong written and verbal communications skills.
- Strong attention to detail.
- Understanding of statistical tools and analysis.
- Excellent interpersonal 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.
**Preferred Qualifications:**
- Preferred experience in monoclonal antibodies, microbially expressed products, and/or peptide intermediates.
- Previous experience supervising/leading people.
- Demonstrated understanding of computer applications.