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

Job Description

Position Overview

Quality Lead, Director– QMS & Digital Quality Governance Analytical

Global Quality Management Systems

The Global Quality Group within our Company Manufacturing Division is seeking an experienced transformation lead in the capacity of Director– Quality Management Systems (QMS) & Digital Quality Governance, to provide strategic and operational leadership for the QMS workstream within a complex, enterprise-level laboratory transformation program.

This role is accountable for architecting, modernizing, and deploying a modernized, digitized Quality Management System tailored to support 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 (ICH Q9), and computerized systems validation (CSV/CSA)—to ensure seamless integration with modern automated laboratory workflows, LIMS, ELN, and digital data pipelines. In close partnership with the program leadership team, Site Quality heads, Analytical Development, Digital/IT Quality, and Regulatory Compliance, the incumbent will ensure that innovative operational models maintain rigorous compliance with global health authority regulations while driving efficiency, inspection readiness, and continuous improvement.

Key Responsibilities and Requirements

The ideal candidate will combine deep technical expertise in global Quality Management Systems with a forward-thinking innovation mindset, translating digital and automated laboratory advancements into agile, compliant, and sustainable QMS frameworks.

• •Strategic QMS Architecture & Modernization: Define, lead, and execute the QMS integration strategy for the lab transformation initiative, ensuring core quality processes (Change Control, OOS/OOE/OOT investigations, Deviations, CAPA, Method Transfer/Validation, and Batch Release support) are optimized, digitized, and natively integrated with automated laboratory systems
• •Coding Experience: Experience and understanding on how coding translates to QMS and analytical functions. Responsible for overseeing the eQMS and ability to be able to review and understand the underlying code and how it is ensures compliance.
• •Digital Quality & Data Integrity Governance: Partner with IT/Digital Quality and Automation engineers to embed robust Data Integrity by Design (ALCOA+) and Computer Software Assurance (CSA) principles into digitized laboratory platforms, instrument interfaces, and automated data flows.
• •Regulatory Compliance & Inspection Readiness: Ensure all modernized QMS processes, policies, and standard operating procedures (SOPs) comply with global cGMP regulations (FDA 21 CFR Part 11/210/211, EU Annex 11, ICH Q9/Q10, WHO). Drive inspection readiness strategies and author/review corresponding regulatory briefing documents and filing sections.
• •Matrixed Program Leadership & Governance: Direct the QMS workstream governance forum, actively tracking milestone execution, interdependencies, risks, and critical paths. Provide regular data-driven progress updates, risk assessments, and escalation pathways to the Overall Quality Lead and executive steering bodies.
• •Change Management & Operational Transition: Drive human-centered change management and training initiatives to support site-level and global QC laboratory adoption of digitized quality workflows, fostering a strong culture of quality and transformation agent mindset.
• •Cross-Functional Collaboration: Serve as the central quality authority across laboratory operations, technology development, computerized systems validation, and regulatory affairs, eliminating silos and resolving complex compliance roadblocks.
• •People Leadership & Oversight: Supervise and mentor quality specialists, compliance leads, and external consultants supporting QMS transformation, maintaining high standards of technical rigor, accountability, and development.

Required Experience

• •Education: Bachelor’s degree in Chemistry, Biochemistry, Pharmacy, Engineering, Life Sciences, or related discipline required; advanced degree (Master’s, PhD, PharmD, or MBA) strongly preferred.
• •Experience: 10+ to 15+ years of progressive experience in pharmaceutical/biopharmaceutical quality operations, quality systems, or compliance within a cGMP manufacturing and QC laboratory environment.
• •Quality Systems Expertise: Proven track record in designing, optimizing, and overseeing enterprise-level QMS processes (Deviations, Investigations, CAPA, Change Control, Out of Specification, and Quality Risk Management) in laboratories subject to global health authority inspections (e.g., FDA, EMA, PMDA).
• •Digital & Laboratory Systems Acumen: In-depth knowledge of laboratory digital ecosystems, including LIMS, ELN, CDS, SDMS, automated instrumentation, and their integration into enterprise QMS platforms (e.g., TrackWise, Veeva Vault QMS).
• •Validation & Compliance Mastery: Strong understanding of Data Integrity expectations, 21 CFR Part 11, EU Annex 11, and modern risk-based validation methodologies (GAMP 5, Computer Software Assurance).
• •Governance & Program Execution: Demonstrated success leading large-scale cross-functional workstreams, setting project milestones, proactively managing risk registers, and driving accountable execution.
• •Communication & Influencing: Exceptional written and verbal communication skills, with proven ability to present technical compliance strategies effectively to executive sponsors, auditors, and technical teams.

Preferred Experience

• •Direct experience leading or supporting QMS transformation initiatives (e.g., transition from paper/hybrid 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 (PAIs), and authoring QMS/Quality sections for regulatory dossiers (NDA, BLA, MAA).
• •Practical application of Lean / Six Sigma methodologies to streamline quality workflows and cycle times.
• •Programming experience is an asset, and or strong demonstrated ability to quickly learn.
• •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.

Required Skills:

Analytical Development, Cross-Functional Leadership, Digital Transformation, Enterprise Transformation, Executive Communications, GMP Compliance, Laboratory Quality Control, Project Governance, Quality Management Systems (QMS), Regulatory Strategies

Preferred Skills:

Analytical Testing, Change Leadership, Program Governance

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