Senior Director, Commercial GMP Quality
MDWerks Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $220,000 - $250,000 per year
Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GMP Quality SystemsQuality AssuranceProduct ReleaseRegulatory InspectionsBatch Records ReviewInspection ReadinessTech TransfersLifecycle Management
Soft Skills
LeadershipCollaborationCommunication
Certifications
Bachelor’s degreePh.D. or advanced degree