Quality Lead – Drug Substance Capital Projects

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

Benefits offered by this job

Annual bonus

Comprehensive benefits

Job summary

Merck in USA - Pennsylvania - West Point is seeking an Associate Director, Quality to provide quality direction for a Drug Substance capital project. You will lead GMP compliance, quality systems, training, change control, inspection readiness, and risk management across the site.

This role requires strong CGMP/regulatory knowledge, leadership, and the ability to drive cross-functional teams through design, qualification, and approval phases, with exposure to regulatory inspections.

Qualifications

• Bachelor's degree with 8+ years in Operations, Quality, Technical Operations, Engineering, Maintenance, or Supply Chain; or
• Master's degree with 6+ years in related area.

Responsibilities

• Executing quality system functions relating to GMP compliance and coordinating multi-department teams.
• Ensuring personnel operate within policies and CGMP regulations.
• Ensuring safety and environmental compliance.
• Serving on governance committees, Technical/Operations Reviews, and regulatory forums.
• Acquiring and maintaining technical process knowledge for decision making.
• Reviewing and approving deviations, CAPAs, commitments, and change requests.
• Primary Quality lead for Capital Project design, qualification and approval.

Skills

Aseptic Processing

CGMP Knowledge

Audit Management

Regulatory Understanding

Leadership

Problem Solving

Education

Bachelor's Degree in Science/Engineering or technical field

Master's Degree in Science/Engineering

Job description

Merck in USA - Pennsylvania - West Point is seeking an Associate Director, Quality to provide quality direction for a Drug Substance capital project. You will lead GMP compliance, quality systems, training, change control, inspection readiness, and risk management across the site.

This role requires strong CGMP/regulatory knowledge, leadership, and the ability to drive cross-functional teams through design, qualification, and approval phases, with exposure to regulatory inspections.