Associate Director Quality
$129k - $203.1kMerck
Merck seeks an Associate Director, Quality to lead quality oversight and compliance for a drug substance capital project. The role manages quality systems, regulatory alignment, and cross-functional teams while ensuring GMP compliance and facility qualification at the West Point manufacturing site.
Responsibilities
- Execute quality system functions related to GMP compliance and direct multi-department support teams
- Ensure personnel comply with company policies, cGMPs, and applicable government regulations
- Review and approve compliance documents including deviations, CAPAs, and change requests
- Serve as primary quality lead for capital project design, qualification, and approval phases
- Participate in regulatory inspections and interact with regulatory agencies during pre-approval activities
Requirements
- Bachelor's in Science/Engineering with 8 years relevant experience, or Master's with 6 years
- Minimum 2 years managing direct reports
- Strong understanding of cGMPs, FDA, and EMEA regulatory standards
- Proven analytical and critical thinking skills
- Experience with capital project quality oversight and design qualification
- Demonstrated success leading cross-functional teams and managing multiple projects
Vacancy posted 3 days ago
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