Associate Director, Quality — Site Leader (Bonus Eligible)

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

Job summary

Merck & Co. is seeking an Associate Director of Quality to provide direction and oversight for our site’s quality systems, including training, documentation, change control, and inspection management.

The role leads a team of Quality Specialists to ensure products are manufactured and tested in compliance with regulatory and internal standards. The candidate will drive continuous improvement, maintain CGMP compliance, and collaborate across operations to align on priorities and risk management.

Qualifications

• Bachelor's degree in science, Engineering, or another technical field with eight (8) years' experience in a functional area.
• Master's degree in Science, Engineering, or another technical field with six (6) years' experience in a functional area.
• Strong understanding of CGMPs, FDA, and EMEA regulatory standards.
• Minimum two (2) concurrent years' experience in the Quality Area in a controlled GMP environment.

Responsibilities

• Provide quality direction and oversight to site according to quality systems.
• Lead development, execution, and deployment of site priorities.
• Manage a team of Quality Specialists working with operations leaders.
• Ensure products are manufactured and tested per approved processes and compliance requirements.

Skills

CGMPs

FDA/EMEA

Analytical thinking

GMP environment

Auditing

Quality leadership

Direct reports

Risk management

Lean processing

Aseptic processing

Pharma manufacturing

Education

Bachelor's degree

Master's degree

Job description

Merck & Co. is seeking an Associate Director of Quality to provide direction and oversight for our site’s quality systems, including training, documentation, change control, and inspection management.

The role leads a team of Quality Specialists to ensure products are manufactured and tested in compliance with regulatory and internal standards. The candidate will drive continuous improvement, maintain CGMP compliance, and collaborate across operations to align on priorities and risk management.