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Director– Quality Management Systems (QMS) & Digital Quality Governance

Merck · Posted Nov 5, 2026

Wilmington, Delaware, United States
Hybrid
Full-time · Director
$173K–$273K per year
10–15 years

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Strategic and operational leadership for the QMS workstream within a complex, enterprise-level laboratory transformation program, focusing on architecting and deploying a modernized, digitized Quality Management System.

Compensation

$173,200 - $272,600

Responsibilities

Define, lead, and execute the QMS integration strategy for the lab transformation initiative.
Oversee harmonization and evolution of quality processes including deviation management, investigations, CAPA, change control, risk management (ICH Q9), and computerized systems validation (CSV/CSA).
Oversee the eQMS and review/understand underlying code to ensure compliance.
Partner with IT/Digital Quality and Automation engineers to embed Data Integrity by Design (ALCOA+) and Computer Software Assurance (CSA) principles.
Ensure all modernized QMS processes, policies, and SOPs comply with global cGMP regulations (FDA 21 CFR Part 11/210/211, EU Annex 11, ICH Q9/Q10, WHO).

Requirements

Bachelor’s degree in Chemistry
Biochemistry
Pharmacy
Engineering
Life Sciences

Skills

Quality Management Systems (QMS)cGMP QC laboratory

Manager - CMO Quality

Manager - CMO Quality

Responsibilities

Requirements

Skills

Director– Quality Management Systems (QMS) & Digital Quality Governance

Compensation

Responsibilities

Requirements

Skills