Associate Director, External GMP Quality Assurance

Merck & Co.; West Point (PA); Hybrid; USD 129,000 - 203,000; Full time

Benefits offered by this job

Medical insurance

Retirement benefits (401(k))

Job summary

Merck & Co. is seeking a senior professional to lead quality oversight for external entities (CMOs) in the Clinical Finished Goods platform.

The role involves acting as the quality representative to ensure GMP compliance, coordinating with R&D, and driving strategic quality initiatives across vendors and contractors. The position requires extensive experience in pharmaceutical quality systems, regulatory compliance, and complex cross-functional leadership to manage audits, investigations, and

Qualifications

• Bachelor's degree with 10+ years of relevant pharma experience or Advanced Degree with 8+ years of relevant experience.
• Strong scientific/ technical knowledge; interact with SMEs on initiatives and issue resolution.
• Experience in Clinical Packaging/Labelling, distribution of clinical supplies, and dispositioning.

Responsibilities

• Lead Quality Liaison for Quality Oversight of External Entities/CMOs.
• Oversee Third-Party Vendors in Clinical Finished Goods Platform.
• Lead contractor investigations, review deviations, and approve contractor-initiated investigations.

Skills

Audit Management

Batch Releases

Compliance Investigations

Deviation Management

GMP

Project Leadership

Quality Oversight

Quality Risk Management

Quality Systems Compliance

Regulatory Compliance

Education

Bachelor's degree in Pharmacy, Biology, Engineering, Chemistry or related field

Job description

Merck & Co. is seeking a senior professional to lead quality oversight for external entities (CMOs) in the Clinical Finished Goods platform.

The role involves acting as the quality representative to ensure GMP compliance, coordinating with R&D, and driving strategic quality initiatives across vendors and contractors. The position requires extensive experience in pharmaceutical quality systems, regulatory compliance, and complex cross-functional leadership to manage audits, investigations, and