Director, Analytical Quality & Operations

Merck & Co.; West Point (PA); Hybrid; USD 173,000 - 273,000; Full time

Job summary

Merck & Co. in West Point, PA seeks a Director of Quality Analytical Support to lead a team of analytical SMEs ensuring right-first-time execution and compliance with cGMP/GLP standards. You will drive deviation management, change control, and data integrity across laboratory operations.

The role requires extensive leadership experience, deep analytical expertise across platforms, and a track record of improving production systems within a regulated pharmaceutical environment.

Qualifications

• Minimum 12 years of related industry experience.
• Minimum of 5 years of experience in a cGMP-regulated laboratory environment (Biologics, Vaccines, or Pharmaceutical industry preferred).
• Minimum of 5 years of direct supervisory or team leadership experience in a technical/Quality environment.
• Strong expertise in analytical techniques across multiple platforms (e.g. Chromatography/Separations, Biochemistry, Microbiology, and automated laboratory systems).
• Demonstrated Quality decision-making and critical thinking capabilities.
• In-depth knowledge of cGMP/GLP requirements, regulatory expectations, and compendial compliance.
• Demonstrated ability to effectively write and review technical documents.

Responsibilities

• Lead, coach, and mentor a team of analytical scientists and subject matter experts; conduct regular performance evaluations.
• Manage team capacity and demand; prioritize tasks for schedule adherence and project delivery.
• Oversee technical onboarding and ensure up-to-date training on processes, systems, and compliance.
• Utilize production systems to optimize workflows and drive continuous improvement.
• Lead and participate in tier meetings to align priorities and share best practices.
• Serve as primary contact for technical issues and escalate regulatory concerns promptly.
• Own technical change controls and document changes to methods, equipment, reagents, and key parameters.
• Guide Troubleshooting of complex analytical methods and equipment; foster cross-functional problem-solving.
• Oversee investigations; ensure robust root cause analyses and effective CAPAs.
• Ensure high-quality documentation for investigations and regulatory support.
• Support audits and regulatory inspections; lead responses and compendial assessments.
• Ensure activities comply with cGMP/GLP and regulatory requirements.
• Promote safety culture; integrate safety assessments into technical decisions.

Skills

Analytical Instrumentation

Change Control Management

Change Controls

Change Management

Chemical Analysis

Coaching Feedback

Microbiological Analysis

People Leadership

Production System

Root Cause Identification

Supervision

Talent Development

Technical Investigation

Technical Transfer

Troubleshooting

Workflow Optimization

Workload Management

Education

Bachelor's, Master's, or Ph.D. in Chemistry, Biochemistry, Microbiology, Molecular Biology

Job description

Merck & Co. in West Point, PA seeks a Director of Quality Analytical Support to lead a team of analytical SMEs ensuring right-first-time execution and compliance with cGMP/GLP standards. You will drive deviation management, change control, and data integrity across laboratory operations.

The role requires extensive leadership experience, deep analytical expertise across platforms, and a track record of improving production systems within a regulated pharmaceutical environment.