QMS & Digital Quality Governance Director

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

Benefits offered by this job

Medical, dental, vision coverage

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck & Co. seeks an accomplished Quality Lead, Director for QMS & Digital Quality Governance to steer a global lab transformation. The role drives modernization of the QMS, integration with automated lab systems, and robust data integrity across digitized workflows in a regulated environment.

You will partner with IT, Regulatory, and Site Quality leadership to ensure compliant, efficient operations, with a focus on inspection readiness and continuous improvement.

Qualifications

• Bachelor's degree in a scientific or engineering discipline is required
• Advanced degree strongly preferred (MS/PhD/MBA/PharmD)
• 10+ to 15+ years in pharma/biopharma quality operations or compliance
• Proven QMS design, optimization, and cross-functional governance in regulated labs

Responsibilities

• Define and execute QMS integration for lab transformation, ensuring digitization of core processes
• Oversee deviations, investigations, CAPA, change control, and risk management
• Ensure regulatory alignment with FDA/EMA/ICH and data integrity by design
• Lead cross-functional governance forums and provide data-driven updates to executives
• Mentor quality specialists and manage external partners in regulated settings

Skills

QMS Architecture

Quality Governance

Data Integrity

Regulatory Strategy

Executive Communication

Education

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

Advanced degree (Master's/PhD/PharmD/MBA) preferred

Tools

LIMS

ELN

CDS

SDMS

TrackWise

Job description

Merck & Co. seeks an accomplished Quality Lead, Director for QMS & Digital Quality Governance to steer a global lab transformation. The role drives modernization of the QMS, integration with automated lab systems, and robust data integrity across digitized workflows in a regulated environment.

You will partner with IT, Regulatory, and Site Quality leadership to ensure compliant, efficient operations, with a focus on inspection readiness and continuous improvement.