Strategic Lead, Regulatory QA & Inspections

Merck; West Point (PA); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck is seeking an Associate Director to lead regulatory inspections andHealth Authority reporting at the West Point site. You will oversee a team of compliance professionals, ensuring inspection readiness and robust regulatory oversight across QA operations.

Requirements include a BS/MS in a pharmaceutical field and extensive cGMP/regulatory experience. The role emphasizes cross-functional collaboration, CAPA management, and continuous improvement with strong leadership.

Qualifications

• Experience with quality systems expectations in biotech or vaccine industries.
• Expert knowledge of cGMP for biotech/vaccine sectors including local and international GMPs.
• Strong regulatory knowledge (21 CFR Part 11, Annex 11).
• Ability to work independently and collaborate in matrix organizations.

Responsibilities

• Lead the quality team for Regulatory Inspections and Health Authority reporting.
• Develop and implement comprehensive compliance programs ensuring inspection readiness.
• Coordinate with multiple departments to address compliance issues and implement CAPAs.
• Serve as liaison to Health Authorities and regulatory agencies.
• Oversee Health Authority reporting, market actions, and complaint handling.
• Provide training to employees on compliance matters and PIR.
• Drive continuous improvement and standardization across the site.

Skills

Change Management

CSV

Decision Making

Continuous Improvement

GMP Laboratory

People Leadership

PQ

Quality Auditing

Quality Documentation

Quality Standards

QMS

Quality Risk Management

Regulatory Compliance

Supplier Quality

Training & Development

Education

Bachelor’s or Master’s degree in a pharmaceutical/biotech related field

Job description

Merck is seeking an Associate Director to lead regulatory inspections andHealth Authority reporting at the West Point site. You will oversee a team of compliance professionals, ensuring inspection readiness and robust regulatory oversight across QA operations.

Requirements include a BS/MS in a pharmaceutical field and extensive cGMP/regulatory experience. The role emphasizes cross-functional collaboration, CAPA management, and continuous improvement with strong leadership.