Director, External Quality Control – Stability
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Job Description
Quality control director overseeing analytical testing, stability, suppliers, and regulatory support for Centessa’s sleep-disorder medicines. Leading programs from clinical through commercial development.
Responsibilities:
- Develop and lead analytical quality control strategy across multiple programs
- Review analytical methods, specifications, and validation activities and collaborate on updates
- Support analytical method transfer
- Collaborate on supplier qualification and/or remediation activities
- Oversee stability program design and execution across multiple programs
- Monitor and report on stability trends and product quality attributes
- Ensure ongoing regulatory compliance of stability activities
- Manage ongoing supplier relationships
- Perform routine reviews of testing results and quality documentation
- Drive issue resolution to facilitate regulatory compliance
- Provide tactical support for regulatory submissions
- Support health authority inspections and audits
- Review analytical and stability sections within CMC filings
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 and providing tactical support for quality control programs
Benefits:
- Company bonus depending in part on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical, dental, vision, and prescription drug benefits
- Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
- Life insurance and death benefits
- Time off and leave of absence benefits
- Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
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