Director, External Quality Assurance & CMO Oversight

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

Benefits offered by this job

Medical, dental, vision coverage

401(k) retirement plan

Paid holidays and leave

Job summary

MSD Malaysia’s Quality Assurance team is seeking a senior QA professional to provide quality oversight for external entities and CMOs. You will lead investigations, CAPAs, and vendor assessments to ensure GMP compliance across clinical supplies and finished goods.

Role requires extensive experience in pharmaceutical development environments, strong leadership, and collaboration with R&D, procurement, and QA teams to drive strategic quality initiatives.

Qualifications

• Bachelor’s degree with 10+ years in pharma or 8+ years with an advanced degree.
• Strong knowledge of GMP, regulatory standards, and R&D processes.
• Experience with audits, deviations, CAPAs, and vendor oversight.
• Ability to lead cross-functional teams and communicate with senior management.

Responsibilities

• Lead quality liaison for external entities and CMOs.
• Oversee quality oversight of nominated third-party vendors in the FG platform.
• Lead investigation teams for contractor-related deviations and audits.
• Collaborate with QA Disposition, R&D, and Procurement on strategic objectives.
• Develop quality metrics for contractor performance and oversee CAPA/change controls.
• Represent QA in oversight meetings with internal and contractor personnel.
• Investigate significant quality events for external contractors.
• Support clinical supply chain ensuring quality and regulatory compliance of clinical supplies.
• Lead projects in a matrix management environment and strategic planning.

Skills

Leadership

Stakeholder management

Regulatory compliance

Quality systems

Education

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

Job description

MSD Malaysia’s Quality Assurance team is seeking a senior QA professional to provide quality oversight for external entities and CMOs. You will lead investigations, CAPAs, and vendor assessments to ensure GMP compliance across clinical supplies and finished goods.

Role requires extensive experience in pharmaceutical development environments, strong leadership, and collaboration with R&D, procurement, and QA teams to drive strategic quality initiatives.