Director, Digital QMS & Quality Governance

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

Job summary

Merck & Co. is seeking a Quality Lead, Director for QMS & Digital Quality Governance to guide a major laboratory transformation.

You will architect modern QMS, lead digitization, and ensure compliant, efficient lab workflows with LIMS/ELN integration and CSA data integrity principles. The role requires 10+ to 15+ years in pharma quality operations and a strong track record in global compliance, governance, and program execution.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmacy, Engineering, Life Sciences, or related discipline required.
• 10+ to 15+ years of progressive experience in pharma/biopharma quality operations, quality systems, or compliance in cGMP labs.
• Proven track record designing and overseeing enterprise-level QMS processes in regulated labs.
• Deep knowledge of lab digital ecosystems and QMS integration (LIMS/ELN/CDS).
• Strong understanding of Data Integrity, 21 CFR Part 11, EU Annex 11, GAMP 5 and CSA.

Responsibilities

• Define, lead and execute the QMS integration strategy for the lab transformation.
• Digitize core quality processes and ensure native integration with automated lab systems.
• Oversee deviations, investigations, CAPA, Change Control and risk management in QMS.
• Ensure regulatory compliance and inspection readiness across global operations.
• Lead governance forums and provide data-driven progress updates.

Skills

Analytical Development

Cross-Functional Leadership

Digital Transformation

Enterprise Transformation

Executive Communications

GMP Compliance

Laboratory Quality Control

Project Governance

Quality Management Systems (QMS)

Regulatory Strategies

Education

Bachelor's degree in Chemistry, Biochemistry, Pharmacy, Engineering, Life Sciences, or related discipline

Advanced degree (Master's, PhD, PharmD, or MBA) strongly preferred

Tools

LIMS

ELN

CDS

SDMS

TrackWise

Veeva Vault QMS

Job description

Merck & Co. is seeking a Quality Lead, Director for QMS & Digital Quality Governance to guide a major laboratory transformation.

You will architect modern QMS, lead digitization, and ensure compliant, efficient lab workflows with LIMS/ELN integration and CSA data integrity principles. The role requires 10+ to 15+ years in pharma quality operations and a strong track record in global compliance, governance, and program execution.