Director, Quality Analytics & Lab Operations (Hybrid)

MSD; West Point (PA); Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

MSD seeks a Director of Quality Analytical Support to lead a team of analytical SMEs supporting West Point operations. The role emphasizes cGMP/GLP compliance, deviation/change control, and robust data integrity across multiple platforms.

You will drive continuous improvement, oversee investigations and CAPAs, and coordinate cross-functional collaboration with QA, Manufacturing, Engineering, and global partners to ensure right-first-time execution.

Qualifications

• Minimum of 12 years of related industry experience.
• Minimum of 5 years 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

• People Leadership: Lead, coach, and mentor a team of analytical scientists and subject matter experts.
• Workload & Resource Planning: Manage team capacity and demand; ensure schedule adherence.
• Training & Onboarding: Oversee technical onboarding and ongoing training.
• Continuous Improvement: Utilize production systems to optimize workflows and reduce waste.
• Tier Governance: Participate in tier meetings to align priorities with business needs.
• Escalation Management: Serve as primary contact for technical issues and critical concerns.
• Change Control Management: Author, review, and own technical change controls.
• Troubleshooting: Guide the team in resolving complex analytical method issues.
• Quality Investigations: Oversee complex investigations and CAPA actions.
• Documentation Standards: Ensure high-quality investigation reports and regulatory documents.
• Audit & Inspection Support: Act as technical resource during regulatory inspections.
• Regulatory Compliance: Ensure activities comply with cGMPs, GLPs, and local procedures.
• Safety Culture: Integrate safety assessments into technical decisions.

Skills

People Leadership

Analytical Techniques

cGMP/GLP Knowledge

Documentation & Regulatory Writing

CAPA & Change Control

Problem Solving

Education

Bachelor's/Master's/Ph.D. in Chemistry/Biology/Related Sciences

Job description

MSD seeks a Director of Quality Analytical Support to lead a team of analytical SMEs supporting West Point operations. The role emphasizes cGMP/GLP compliance, deviation/change control, and robust data integrity across multiple platforms.

You will drive continuous improvement, oversee investigations and CAPAs, and coordinate cross-functional collaboration with QA, Manufacturing, Engineering, and global partners to ensure right-first-time execution.