Sr. Director - API Manufacturing Quality Assurance
Posted 2 months ago Expired
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Upload Your ResumeAbout This Role
Serve as the Site Quality Leader overseeing manufacturing, utilities, laboratories, and warehousing for a new API manufacturing facility. Ensure compliance with cGMPs, procedures, standards, and regulatory commitments, and lead the API Quality Team.
Responsibilities
- Serve as Site Quality Leader on the Lilly Site Lead Team
- Ensure site-wide compliance with cGMPs, procedures, standards, and regulatory commitments
- Lead the API Quality Team and manage its agenda
- Support quality forums (e.g., Deviation and Change Control Boards)
- Develop and monitor a site Quality Plan and metrics
- Coordinate and manage regulatory inspections
- Review and approve manufacturing and quality system documents
- Ensure adequate QA staffing and provide coaching and development
- Use HR tools for performance management, staffing, and succession planning
- Contribute to QA business planning and site-wide strategic planning
Requirements
- Bachelor's degree
- 10+ years of pharmaceutical manufacturing quality experience
- 5+ years of supervision/leadership experience
Qualifications
- Bachelor's degree (STEM degree preferred)
- 10+ years of pharmaceutical manufacturing quality experience, 5+ years of supervision/leadership experience
Nice to Have
- Experience in Manufacturing, Development, QC, Technical Services, Engineering, or Regulatory Affairs
- Proficient in statistical analysis and computer applications
- Strong interpersonal, communication, and networking skills
- Ability to influence diverse teams and manage multiple priorities
- Demonstrated problem-solving and analytical thinking
Benefits
About BioSpace
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, specializing in discovering and bringing life-changing medicines to patients worldwide. They are investing over $1 billion to create a new state-of-the-art manufacturing site in Concord, NC, focusing on parenteral medication...