Director of Analytical Quality & Compliance

MSD Malaysia; West Point (PA); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck & Co., Inc. in West Point, PA is seeking a Director of Quality Analytical Support to lead a team of analytical SMEs, ensuring cGMP/GLP compliance and driving continuous improvement within laboratory operations.

You will manage daily activities, deviation and change control, audits, and regulatory responses, while partnering with Quality, Manufacturing, and global teams to ensure right-first-time results and robust data integrity.

Qualifications

• 12+ years of related industry experience.
• 5+ years in a cGMP-regulated laboratory environment (Biologics, Vaccines, or Pharmaceutical industry preferred).
• 5+ years of direct supervisory or team leadership experience in a technical/Quality environment.
• Strong expertise in analytical techniques across multiple platforms (Chromatography/Separations, Biochemistry, Microbiology, and automated laboratory systems).
• Knowledge of cGMP/GLP requirements and regulatory expectations.
• Ability to write and review technical documents.

Responsibilities

• Lead, coach, and mentor a team of analytical scientists and SMEs.
• Manage team workload, capacity planning, and resource allocation.
• Oversee onboarding and training of new team members.
• Apply continuous improvement using production systems to optimize workflows.
• Lead governance meetings and communicate priorities and performance.
• Serve as primary contact for technical issues and escalation to site leadership.
• Author and own technical change controls and document changes.
• Guide troubleshooting of analytical methods and lab equipment across functions.
• Oversee investigations, root cause analyses, and CAPA tracking.
• Ensure high-quality regulatory documentation and audit support.
• Ensure compliance with cGMP/GLP and international regulations.

Skills

Analytical methods

cGMP/GLP

Team leadership

Quality investigations

Education

Bachelor’s, Master’s, or Ph.D. in Chemistry or related field

Tools

Chromatography

Laboratory systems

Job description

Merck & Co., Inc. in West Point, PA is seeking a Director of Quality Analytical Support to lead a team of analytical SMEs, ensuring cGMP/GLP compliance and driving continuous improvement within laboratory operations.

You will manage daily activities, deviation and change control, audits, and regulatory responses, while partnering with Quality, Manufacturing, and global teams to ensure right-first-time results and robust data integrity.