Director– Quality Management Systems (QMS) & Digital Quality Governance
MSD • Wilmington, DE3d • Hybrid
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Director– Quality Management Systems (QMS) & Digital Quality Governance
MSD•Wilmington, DE
•Hybrid
About The Position
The Global Quality Group within the Company Manufacturing Division seeks an experienced transformation lead to provide strategic and operational leadership for the QMS workstream in an enterprise-level laboratory transformation program. The role is accountable for architecting, modernizing, and deploying a digitized Quality Management System that supports next-generation QC testing, end-to-end analytical digitization, instrumentation innovation, and laboratory automation. The Director will lead the harmonization and evolution of quality processes, including deviation management, investigations, CAPA, change control, risk management, and computerized systems validation. The QMS must integrate with automated laboratory workflows, LIMS, ELN, and digital data pipelines while maintaining global regulatory compliance, inspection readiness, efficiency, and continuous improvement. Working with program leadership, Site Quality heads, Analytical Development, Digital/IT Quality, and Regulatory Compliance, the role will lead QMS governance and transition activities, oversee specialists and consultants, and support adoption of digitized quality workflows across sites and globally. The position is based primarily in Wilmington, Delaware, with hybrid work arrangements and 10% travel. Relocation assistance and visa sponsorship are not available.
Requirements
- Bachelor’s degree in Chemistry, Biochemistry, Pharmacy, Engineering, Life Sciences, or a related discipline.
- 10+ to 15+ years of progressive experience in pharmaceutical or 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, including Deviations, Investigations, CAPA, Change Control, OOS, and Quality Risk Management, in laboratories subject to global health authority inspections.
- In-depth knowledge of laboratory digital ecosystems, including LIMS, ELN, CDS, SDMS, automated instrumentation, and integration with enterprise QMS platforms.
- Strong understanding of data integrity expectations, 21 CFR Part 11, EU Annex 11, and risk-based validation methodologies such as GAMP 5 and Computer Software Assurance.
- Demonstrated success leading large-scale cross-functional workstreams, setting milestones, managing risk registers, and driving accountable execution.
- Exceptional written and verbal communication skills and ability to present compliance strategies to executive sponsors, auditors, and technical teams.
- Experience and understanding of how coding translates to QMS and analytical functions, including the ability to review and understand underlying eQMS code.
Nice To Haves
- Advanced degree such as a Master’s, PhD, PharmD, or MBA.
- Direct experience leading or supporting QMS transformation, including transitions from paper or hybrid systems to end-to-end digitized paperless QC environments.
- Working knowledge of automated testing platforms, robotics, or continuous manufacturing/testing control frameworks.
- Experience with global health authority inspections and pre-approval inspections (PAIs), and authoring QMS/Quality sections for NDA, BLA, or MAA regulatory dossiers.
- Practical application of Lean or Six Sigma methodologies to streamline quality workflows and cycle times.
- Programming experience, or a strong demonstrated ability to learn programming quickly.
- Experience supporting enterprise workforce strategy, technology evaluation, or transition initiatives.
- Experience managing external third-party service providers, software vendors, and implementation partners in regulated environments.
Responsibilities
- Define, lead, and execute the QMS integration strategy for the laboratory transformation initiative.
- Optimize, digitize, and integrate Change Control, OOS/OOE/OOT investigations, Deviations, CAPA, Method Transfer/Validation, and Batch Release support with automated laboratory systems.
- Oversee the eQMS and review and understand its underlying code and how it ensures compliance.
- Partner with IT/Digital Quality and Automation engineers to embed ALCOA+ data integrity and Computer Software Assurance principles into laboratory platforms, instrument interfaces, and automated data flows.
- Ensure modernized QMS processes, policies, and SOPs comply with global cGMP requirements, including FDA 21 CFR Part 11/210/211, EU Annex 11, ICH Q9/Q10, and WHO requirements.
- Drive inspection-readiness strategies and author or review regulatory briefing documents and filing sections.
- Direct the QMS workstream governance forum, tracking milestones, interdependencies, risks, and critical paths.
- Provide data-driven progress updates, risk assessments, and escalations to the Overall Quality Lead and executive steering bodies.
- Lead human-centered change management and training to support adoption of digitized quality workflows at site and global QC laboratories.
- Serve as the central quality authority across laboratory operations, technology development, computerized systems validation, and regulatory affairs, resolving compliance roadblocks.
- Supervise and mentor quality specialists, compliance leads, and external consultants supporting the QMS transformation.
Benefits
- Medical, dental, and vision healthcare and other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, compassionate days, and sick days.
- Eligible for an annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Director
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