Associate Director, Quality Assurance

Merck · West Point, PA

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QualityFull-time$142k–$224kCompany career page

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What they're looking for

Bachelor's degree or Master's degree with 10+ years pharmaceutical quality, compliance, or manufacturing experience
Expert knowledge of cGMP regulations relevant to biotechnology or vaccine industry
In-depth understanding of FDA regulations including 21 CFR Part 11 and Annex 11
Strong quality management systems knowledge and regulatory compliance expertise
Proven leadership experience managing cross-functional teams in matrix organizations
Excellent communication, technical writing, and problem-solving skills

What you'll be doing

Develop and implement comprehensive compliance programs ensuring permanent inspection readiness and health authority reporting
Conduct compliance risk assessments, identify potential risks, and develop mitigation strategies
Lead team responding to regulatory agency inquiries and managing inspection coordination with health authorities
Provide compliance training and guidance to employees across the site
Drive continuous improvement initiatives and simplification efforts across quality operations

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