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

MSD

. Provide strategic and operational leadership for the QMS workstream within an enterprise-level laboratory transformation program .

Posted 11/5/2026full-timeUnited StatesLead💰 $173,200 - $272,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management System (QMS) architecture and compliance within cGMP environments, with a strong focus on regulatory standards and data integrity principles. Proven ability to lead cross-functional teams and manage complex projects in pharmaceutical quality operations.

Highest-signal resume keywords

Quality Management System (QMS) DesignCGMP ComplianceData Integrity PrinciplesRegulatory Affairs ExperienceCross-Functional Leadership

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Applicant Tracking System Keywords

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Hard Skills

Quality Risk ManagementDeviations ManagementCAPA ImplementationChange Control ProcessesAnalytical DigitizationLaboratory AutomationCoding ExperienceEnterprise QMS IntegrationMethod Transfer/ValidationInspection Readiness

Soft Skills

Exceptional Communication SkillsLeadership and MentoringChange Management

Tools & Technologies

LIMSELNCDSSDMSTrackWiseVeeva Vault QMSAutomated Instrumentation

Industry Keywords

Pharmaceutical Quality OperationsBiopharmaceutical ComplianceFDA RegulationsEU Annex 11ICH Q9/Q10WHO RequirementsLean/Six SigmaHealth Authority Inspections

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Provide strategic and operational leadership for the QMS workstream within an enterprise-level laboratory transformation program
Architect, modernize, and deploy a digitized Quality Management System for next-generation QC testing, analytical digitization, instrumentation innovation, and laboratory automation
Define and execute QMS integration strategy across Change Control, OOS/OOE/OOT investigations, Deviations, CAPA, Method Transfer/Validation, and Batch Release support
Oversee the eQMS and review underlying code to ensure compliance
Partner with IT/Digital Quality and Automation engineers to implement Data Integrity by Design and Computer Software Assurance principles
Ensure QMS processes, policies, and SOPs comply with global cGMP regulations
Drive inspection readiness and author or review regulatory briefing documents and filing sections
Direct QMS workstream governance, track milestones, interdependencies, risks, and critical paths
Provide data-driven updates, risk assessments, and escalations to the Overall Quality Lead and executive steering bodies
Lead change management and training for adoption of digitized quality workflows
Serve as central quality authority across laboratory operations, technology development, CSV, and regulatory affairs
Supervise and mentor quality specialists, compliance leads, and external consultants
Collaborate with Site Quality heads, Analytical Development, Digital/IT Quality, Regulatory Compliance, and program leadership

Requirements

What you’ll need

Bachelor’s degree in Chemistry, Biochemistry, Pharmacy, Engineering, Life Sciences, or related discipline required
10+ to 15+ years of progressive experience in pharmaceutical/biopharmaceutical quality operations, quality systems, or compliance within a cGMP manufacturing and QC laboratory environment
Proven experience designing, optimizing, and overseeing enterprise-level QMS processes
Experience with Deviations, Investigations, CAPA, Change Control, Out of Specification, and Quality Risk Management
Experience in laboratories subject to global health authority inspections, including FDA, EMA, and PMDA
In-depth knowledge of LIMS, ELN, CDS, SDMS, automated instrumentation, and enterprise QMS integrations such as TrackWise and Veeva Vault QMS
Strong understanding of Data Integrity, 21 CFR Part 11, EU Annex 11, GAMP 5, and Computer Software Assurance
Demonstrated success leading large-scale cross-functional workstreams and managing project milestones, risks, and execution
Exceptional written and verbal communication skills
Coding experience and understanding of how coding translates to QMS and analytical functions
Knowledge of global cGMP regulations, including FDA 21 CFR Part 11/210/211, EU Annex 11, ICH Q9/Q10, and WHO requirements
Preferred: advanced degree (Master’s, PhD, PharmD, or MBA)
Preferred: QMS transformation, automated testing, robotics, continuous manufacturing/testing, health authority inspections, regulatory dossier authoring, Lean/Six Sigma, programming, workforce strategy, technology evaluation, and vendor management experience
Must be a US or Puerto Rico resident
No visa sponsorship available
10% travel required

Benefits

Comp & perks

Annual bonus and long-term incentive, if applicable
Medical, dental, and vision healthcare
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate days
Sick days
Hybrid work arrangement
No relocation required