Associate Director, Quality & Capital Projects

MSD; West Point (PA); On-site; USD 129,000 - 203,000; Full time

Job summary

MSD is seeking an Associate Director of Quality to provide direction for a Drug Substance capital project and oversee quality systems. The role requires strong CGMP knowledge, regulatory interaction, and leadership across cross-functional teams.

The candidate will lead quality improvement, ensure site compliance, and drive risk management while partnering with operations and technical teams to qualify facilities and processes for regulatory readiness.

Qualifications

• Bachelor's degree with eight years in Operations, Quality, or related field.
• Master's degree with six years in Operations, Quality, Tech Ops, or Supply Chain.

Responsibilities

• Execute quality system functions to support GMP compliance.
• Lead capital project quality oversight from design through approval.
• Review deviations, CAPAs, and change requests for compliance.
• Interact with regulatory inspectors during pre-approval inspections.

Skills

Aseptic Processing

Audit Management

Change Controls

Quality Management Systems

CGMP Training

Regulatory Knowledge

Education

Bachelor's degree in Science/Engineering

Master's degree in Science/Engineering

Job description

MSD is seeking an Associate Director of Quality to provide direction for a Drug Substance capital project and oversee quality systems. The role requires strong CGMP knowledge, regulatory interaction, and leadership across cross-functional teams.

The candidate will lead quality improvement, ensure site compliance, and drive risk management while partnering with operations and technical teams to qualify facilities and processes for regulatory readiness.