Senior Director, Commercial GMP Quality
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Job Description
Senior Director overseeing GMP Quality strategies and compliance for a biotech company. Leading initiatives that ensure product quality and regulatory compliance across manufacturing operations.
Responsibilities:
- Lead the development and execution of the Commercial GMP Quality strategy aligned with corporate objectives and regulatory expectations.
- Serve as the primary GMP Quality leader for commercial manufacturing activities.
- Partner with cross-functional leadership to support product launches, tech transfers, and lifecycle management initiatives.
- Oversee the design, implementation, and governance of robust GMP Quality Systems.
- Ensure continued inspection readiness across all GMP operations.
- Provide final Quality review and disposition of commercial drug product and drug substance.
- Ensure compliant and efficient review of master and executed batch records.
- Serve as the senior quality representative for GMP contract manufacturers (CMOs).
- Lead GMP-related inspections and audits and manage responses.
Requirements:
- Bachelor’s degree in life sciences, chemistry, or related discipline required; Ph.D. or advanced degree preferred
- Minimum 15 years of experience in GMP Quality Assurance roles within the pharmaceutical or biotech industry, including at least 5 years in a senior leadership capacity
- Extensive experience in commercial manufacturing, product release, regulatory inspections, and third-party quality oversight
- Strong knowledge of global GMP regulations and industry best practices
Benefits:
- medical
- dental
- vision
- time off
- 401K
- participating in Mineralys incentive plans
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