Director– Quality Management Systems (QMS) & Digital Quality Governance
About The Position
The Global Quality Group within the Company Manufacturing Division is seeking an experienced transformation lead to provide strategic and operational leadership for the QMS workstream within an enterprise-level laboratory transformation program. The Director will architect, modernize, and deploy a digitized Quality Management System that supports next-generation QC testing, end-to-end analytical digitization, instrumentation innovation, and laboratory automation. The role oversees harmonization and evolution of quality processes—including deviation management, investigations, CAPA, change control, risk management, and computerized systems validation—to integrate with automated laboratory workflows, LIMS, ELN, and digital data pipelines. In partnership with program leadership, Site Quality heads, Analytical Development, Digital/IT Quality, and Regulatory Compliance, the Director will ensure new operational models meet global health authority requirements while supporting efficiency, inspection readiness, and continuous improvement. The role leads the QMS workstream governance forum, oversees eQMS and its underlying code and compliance implications, and guides quality specialists, compliance leads, and external consultants. It also drives change management and training to support adoption of digitized quality workflows across global and site-level QC laboratories.
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.
- Demonstrated 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, and automated instrumentation, and their 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, establishing 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.
- Analytical Development, Cross-Functional Leadership, Digital Transformation, Enterprise Transformation, Executive Communications, GMP Compliance, Laboratory Quality Control, Project Governance, Quality Management Systems (QMS), and Regulatory Strategies.
Nice To Haves
- Advanced degree (Master’s, PhD, PharmD, or MBA).
- Direct experience leading or supporting QMS transformation initiatives, such as transition from paper or hybrid processes 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 methods to streamline quality workflows and cycle times.
- Programming experience, or strong demonstrated ability to learn 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.
- Analytical Testing, Change Leadership, and Program Governance.
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.
- Oversee the eQMS and review and understand underlying code and how it supports compliance and analytical functions.
- 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 QMS processes, policies, and SOPs comply with global cGMP regulations and drive inspection-readiness strategies.
- Author or review regulatory briefing documents and filing sections.
- Direct QMS workstream governance, tracking milestones, interdependencies, risks, and critical paths; provide progress updates, risk assessments, and escalations to the Overall Quality Lead and executive steering bodies.
- Drive human-centered change management and training for site-level and global QC laboratory 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.
Benefits
- Medical, dental, and vision healthcare benefits.
- Other insurance benefits for employees and families.
- Retirement benefits, including a 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
