Director, Digital QMS & Quality Governance

Merck & Co.; Wilmington (DE); Hybrid; USD 173,000 - 273,000; Full time

Job summary

Merck & Co. is seeking a Director-level Quality Management Systems (QMS) & Digital Quality Governance lead to drive the transformation of our laboratory quality platform in the Wilmington area.

This role blends strategic QMS architecture with hands-on modernization of processes, data integrity, and automation across LIMS, ELN, and enterprise QMS platforms. You will partner with IT, Regulatory, and site leadership to ensure compliant, efficient operations, while guiding cross-functional teams

Qualifications

• Bachelor's degree in a science/engineering field required; advanced degree preferred.
• 10–15+ years in pharmaceutical/biopharmaceutical quality operations, quality systems, or compliance.
• Experience designing, optimizing, and overseeing enterprise-level QMS processes in regulated labs.
• Knowledge of data integrity and regulatory inspections (FDA/EMA/PMDA).

Responsibilities

• Define, lead, and execute the QMS integration strategy for the lab transformation.
• Oversee deviations, investigations, CAPA, change control, and risk management.
• Ensure QMS processes comply with global cGMP regulations and enable inspection readiness.
• Lead governance forums and provide data-driven progress updates.
• Drive change management and training for digitized QC workflows.
• Collaborate across sites, IT, and regulatory affairs to remove compliance roadblocks.
• Mentor quality specialists and external consultants.

Skills

QMS Architecture

Digital Transformation

Regulatory Compliance

Program Governance

Communication

Change Management

Leadership

Education

Bachelor's degree in Chemistry/Biochemistry/Pharmacy/Engineering/Life Sciences

Advanced degree preferred

Tools

LIMS

ELN

CDS

TrackWise

Veeva Vault QMS

Job description

Merck & Co. is seeking a Director-level Quality Management Systems (QMS) & Digital Quality Governance lead to drive the transformation of our laboratory quality platform in the Wilmington area.

This role blends strategic QMS architecture with hands-on modernization of processes, data integrity, and automation across LIMS, ELN, and enterprise QMS platforms. You will partner with IT, Regulatory, and site leadership to ensure compliant, efficient operations, while guiding cross-functional teams