Director, Quality Control Contractor
Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company•Boston, MA
•$95 - $120•Remote
About The Position
The Director, Quality Control (contractor) will provide leadership and oversight for analytical testing, stability programs, specification management, and quality control activities supporting clinical and commercial development.
Requirements
- BS/MS/PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field.
- 10+ years quality control and analytical development experience.
- Experience developing strategic vision as well as providing tactical support for quality control programs.
Responsibilities
- Develop and Lead analytical quality control strategy across multiple programs.
- Review analytical methods, specifications, and validation activities for adequacy and collaborate on updates, as required.
- Support analytical method transfer, as required.
- Collaborate on supplier qualification and/or remediation activities.
- Oversee the stability program design and execution across multiple programs.
- Monitor and report on stability trends and product quality attributes as required.
- Ensure ongoing regulatory compliance of stability activities.
- Manage supplier ongoing relationships.
- Perform routine reviews of testing results and overall quality of documentation.
- Drive issue resolution to facilitate regulatory compliance.
- Provide tactical support for regulatory submissions.
- Support health authority inspections and audits, as required.
- Review analytical and stability sections within CMC filings.
Benefits
- medical plans, including PPO and EPO options
- dental coverage
- vision coverage
- 401(k)
- wellness programs
- other discounts
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What This Job Offers
Career Level
Director
Education Level
Ph.D. or professional degree
