Lilly is constructing an advanced manufacturing facility for API molecules and needs a Site Quality Leader to ensure GMP manufacturing operations are successful, overseeing quality and compliance systems, activities, and personnel.
Requirements
- 10+ years of pharmaceutical manufacturing quality experience
- 5+ years of supervision/leadership experience
- Experience in Manufacturing, Development, QC, Technical Services, Engineering, or Regulatory Affairs
- Proficient in statistical analysis and computer applications
Responsibilities
- Ensures the strength and continuous improvement of all quality and compliance systems, activities, and personnel.
- Maintaining utilities and ensuring that raw materials and drug substances are produced and released in accordance with cGMP standards and marketing authorization requirements.
- Ensure site-wide compliance with cGMPs, procedures, standards, and regulatory commitments.
- 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.
Other
- Serve as Site Quality Leader on the Lilly Site Lead Team.
- Lead the API Quality Team and manage its agenda.
- 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.
- Strong interpersonal, communication, and networking skills
- Ability to influence diverse teams and manage multiple priorities
- Demonstrated problem-solving and analytical thinking
