Associate Director: External GMP Quality Oversight

MSD; Rahway (NJ); Hybrid; USD 129,000 - 203,000; Full time

Job summary

MSD is seeking a senior quality assurance leader to oversee external contractors and CMOs in the Clinical Finished Goods area. You will act as the quality liaison, ensure regulatory compliance, and drive investigations and improvements across the contractor network.

The role requires extensive pharmaceutical industry experience, strong leadership, and the ability to collaborate with R&D, Quality Disposition, and Procurement to safeguard product quality and regulatory adherence.

Qualifications

• Bachelor’s degree with 10+ years of pharma industry experience or an Advanced Degree with 8+ years of relevant experience.
• Strong scientific/technical knowledge in R&D and ability to interact with subject matter experts on initiatives and issue resolution.

Responsibilities

• Act as Lead Quality Liaison for Quality Oversight of External Entities/CMOs.
• Oversee Third-Party Vendors in Clinical Finished Goods Platform and related quality events.
• Lead cross-functional contractor investigations, review deviations, and negotiate site/Global Quality Agreements.
• Participate in contractor GMP audits as SME and develop contractor metrics and quality assessments.
• Collaborate with Quality Disposition, R&D, and Procurement on strategic objectives using external contractors.
• Identify and lead improvements in Contractor and Supplier Systems; drive corrective actions and trend analysis.

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

MSD is seeking a senior quality assurance leader to oversee external contractors and CMOs in the Clinical Finished Goods area. You will act as the quality liaison, ensure regulatory compliance, and drive investigations and improvements across the contractor network.

The role requires extensive pharmaceutical industry experience, strong leadership, and the ability to collaborate with R&D, Quality Disposition, and Procurement to safeguard product quality and regulatory adherence.