Associate Director, Quality & Compliance Leader

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 strategic quality direction for a site, aligning with CGMP standards and regulatory requirements. Lead a team of Quality Specialists while championing continuous improvement and risk-based decision-making across operations and technical operations.

The role requires driving end-to-end quality initiatives, managing audits and inspections, and ensuring adherence to all applicable regulatory and internal requirements to sustain compliant

Qualifications

• Bachelor's or Master’s in a technical field with 6–8 years in Ops/Quality/Technical Operations/etc.
• Strong CGMP and regulatory standards knowledge.
• Experience leading teams in a controlled GMP environment.

Responsibilities

• Provide quality direction and oversight to the site per quality systems.
• Lead quality improvement initiatives and drive risk-based compliance.
• Supervise Quality Specialists and partner with operations to ensure compliant manufacturing and testing.

Skills

GMP Compliance

Regulatory Knowledge

Quality Leadership

Auditing

Risk Management

Cross-functional Collaboration

Education

Bachelor's degree in science/engineering

Master’s degree in science/engineering

Tools

LIMS

Job description

MSD is seeking an Associate Director of Quality to provide strategic quality direction for a site, aligning with CGMP standards and regulatory requirements. Lead a team of Quality Specialists while championing continuous improvement and risk-based decision-making across operations and technical operations.

The role requires driving end-to-end quality initiatives, managing audits and inspections, and ensuring adherence to all applicable regulatory and internal requirements to sustain compliant