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

Merck•Upper Gwynedd Township, PA

6d•$173,200 - $272,600•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 of 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 QMS Quality Lead will oversee the harmonization and evolution of quality processes, including deviation management, investigations, CAPA, change control, risk management, and computerized systems validation. The role ensures these processes integrate with automated laboratory workflows, LIMS, ELN, and digital data pipelines. Working with program leadership, Site Quality heads, Analytical Development, Digital/IT Quality, and Regulatory Compliance, the Director will maintain compliance with global health authority regulations while advancing efficiency, inspection readiness, and continuous improvement. The position also leads QMS integration strategy and governance, embeds data integrity and software assurance principles into digital laboratory platforms, directs change management and adoption, and supervises quality specialists, compliance leads, and external consultants. The primary location is Wilmington, Delaware, with a hybrid work arrangement and 10% travel. Relocation is not offered.

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 in a cGMP manufacturing and QC laboratory environment.
Proven experience designing, optimizing, and overseeing enterprise-level QMS processes, including deviations, investigations, CAPA, change control, out-of-specification processes, and quality risk management.
Experience with laboratories subject to global health authority inspections, such as FDA, EMA, or PMDA.
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, GAMP 5, and Computer Software Assurance.
Demonstrated success leading large-scale cross-functional workstreams, setting project milestones, managing risk registers, and driving accountable execution.
Exceptional written and verbal communication skills, including the ability to present technical compliance strategies to executive sponsors, auditors, and technical teams.
Experience or understanding of how coding translates to QMS and analytical functions, including the ability to review and understand underlying code and its compliance implications.

Nice To Haves

Advanced degree such as a Master’s, PhD, PharmD, or MBA.
Direct experience leading or supporting QMS transformation, including transition 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, pre-approval inspections, 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 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 quality processes—including change control, OOS/OOE/OOT investigations, deviations, CAPA, method transfer and validation, and batch release support—with automated laboratory systems.
Oversee the eQMS and review and understand underlying code as it relates to QMS and analytical functions and compliance.
Partner with IT/Digital Quality and automation engineers to embed ALCOA+ data integrity and Computer Software Assurance principles in digital laboratory platforms, instrument interfaces, and automated data flows.
Ensure modernized QMS processes, policies, and SOPs comply with global cGMP regulations and drive inspection readiness.
Author or review regulatory briefing documents and filing sections.
Direct the QMS workstream governance forum, track milestones, interdependencies, risks, and critical paths, and provide progress updates, risk assessments, and escalations to the Overall Quality Lead and executive steering bodies.
Lead human-centered change management and training to support global and site-level adoption of digitized quality workflows.
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 QMS transformation.
Present technical compliance strategies to executive sponsors, auditors, and technical teams.
Manage external third-party service providers, software vendors, and implementation partners in regulated environments.