Associate Director, Quality Assurance
Merck · West Point, PA
QualityFull-time$129k–$203kCompany career page
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Role summary
Associate Director of Clinical Supplies Quality at Merck provides quality oversight and strategic leadership for clinical supply chain activities across development programs. Ensures clinical supplies meet regulatory requirements, manages global distribution, and leads cross-functional quality initiatives supporting pharmaceutical development portfolios.
What they're looking for
- Bachelor's degree in scientific discipline with 8+ years pharmaceutical or GMP experience; or advanced degree with 6+ years
- Strong technical expertise in R&D clinical supply operations and regulatory compliance
- Demonstrated ability to engage cross-functional stakeholders and influence senior leaders
- Knowledge of continuous improvement methodologies and complex initiative leadership
- Experience with deviation management, product compliance, and regulatory risk assessment
- Preferred experience with Medical Device/Combination Products and emerging technologies
What you'll be doing
- Provide technical quality expertise for clinical supply operations, integration activities, and Medical Device/Combination Products
- Develop quality strategies and lead continuous improvement initiatives aligned with business objectives
- Evaluate and disposition Medical Device/Combination Product materials per regulatory and company requirements
- Coordinate investigations related to deviations and significant quality events across supply chain
- Identify quality trends, compliance gaps, and emerging risks; lead resolution of issues impacting product quality
Privacy & handoff
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