Associate Director, QA & Regulatory Inspections

MSD Malaysia; Northern (KY); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck & Co., Inc. is seeking an Associate Director, Quality Assurance in West Point, PA to lead regulatory inspections coordination and oversee the quality team responsible for Health Authority reporting.

You will ensure site compliance with applicable GMP regulations and drive continuous improvement across Quality Management Systems. The role requires deep regulatory knowledge, strong leadership, and the ability to work in a matrix environment with Operations, Regulatory, and other functions.

Qualifications

• Applicable experience and deep knowledge of quality systems in biotech or vaccine industries.
• Expert knowledge of cGMP for biotech/vaccine sectors and familiarity with 21 CFR Part 11/Annex 11.
• Ability to work independently within a matrix organization and influence stakeholders.

Responsibilities

• Develop and implement comprehensive compliance programs for inspection readiness (PIR).
• Lead regulatory inspections coordination and respond to agency inquiries.
• Mentor a team of compliance professionals and provide training on regulatory topics.
• Sustain continuous improvement of the organization’s quality systems and processes.

Skills

Change Management

CSV

Decision Making

Driving Continuous Improvement

GMP Laboratory

People Leadership

Performance Qualification (PQ)

Quality Auditing

Quality Control Documentation

Quality Management Standards

Quality Management Systems (QMS)

Quality Risk Management

Regulatory Compliance

Supplier Quality Management

Training and Development

Education

Bachelor’s or Master’s degree in a related field

Job description

Merck & Co., Inc. is seeking an Associate Director, Quality Assurance in West Point, PA to lead regulatory inspections coordination and oversee the quality team responsible for Health Authority reporting.

You will ensure site compliance with applicable GMP regulations and drive continuous improvement across Quality Management Systems. The role requires deep regulatory knowledge, strong leadership, and the ability to work in a matrix environment with Operations, Regulatory, and other functions.