Vice President, Quality Management Systems and Digital Compliance

Responsibilities

• Define and execute enterprise-wide QMS strategy aligned with corporate objectives and growth plans
• Serve as executive sponsor for quality system transformation initiatives supporting commercialization readiness
• Lead long-term strategic planning for quality infrastructure investments, technology roadmaps, and organizational capability building
• Anticipate regulatory trends and proactively position the organization to meet evolving compliance requirements
• Champion quality excellence as a competitive differentiator and driver of business value
• Lead enterprise-wide quality transformation and change management initiatives, driving cultural change and operational maturity
• Establish governance structures, decision-making frameworks, and accountability models across the quality system
• Represent Quality in executive forums, strategic planning sessions, and board presentations
• QMS Architecture & Implementation
• Design, implement, and scale comprehensive quality systems from clinical through commercial stages, with focus on advanced therapy medicinal products (ATMPs)
• Own the Quality Management System strategic roadmap with multi-year planning horizons supporting pipeline expansion and future innovations
• Quality Systems Management & Governance
• Provide executive oversight for critical quality processes including Deviations, CAPA, Change Control, Document Control, Complaints, Quality Risk Management, and Data Integrity programs
• Chair Quality Management Review processes, presenting system metrics, trends, and strategic recommendations to executive leadership
• Establish quality intelligence and analytics capabilities to drive data-informed decisions
• Drive continuous improvement initiatives and define KPIs that measure quality system performance and business impact
• eQMS Implementation & Digital Compliance Leadership
• Lead enterprise digital transformation through adoption, validation, and optimization of electronic Quality Management Systems (eQMS)
• Oversee IT Quality, Computer System Validation (CSV), and Data Integrity programs ensuring compliance with 21 CFR Part 11, Annex 11, and GAMP 5
• Champion strategic vision for Data Governance & Integrity programs, including AI/ML quality applications and digital innovation
• Partner with IT leadership on GxP computer systems lifecycle compliance and drive investment decisions for quality technology stack
• Inspection Readiness & Regulatory Compliance
• Ensure enterprise-wide readiness for global regulatory inspections and Pre-Approval Inspections (PAIs)
• Lead critical health authority inspections and third-party GMP audits
• Support regulatory submission strategies and authoring of product licenses and regulatory dossiers
• Enterprise Risk Management & Operational Effectiveness
• Establish enterprise risk management framework integrating quality risk into corporate risk management processes
• Define enterprise quality metrics and drive operational effectiveness through data analytics
• Champion quality by design (QbD) and risk-based thinking
• Develop and oversee risk-based approaches for quality system governance
• Proactive identification and mitigation of compliance risks
• Define common global effectiveness and efficiency metrics to drive end-to-end performance
• Implement key performance indicators (KPIs) to monitor QMS effectiveness and enable data-driven decision-making
• Team Leadership & Talent Development
• Build, develop, and lead a high-performing organization of quality professionals
• Foster a culture of accountability, innovation, and continuous improvement
• Provide executive coaching and mentorship to quality leaders
• Champion diversity, equity, and inclusion initiatives and drive organizational effectiveness through structure optimization and talent acquisition
• Cross-Functional Executive Partnerships
• Serve as strategic partner to R&D, Technical Operations, Supply Chain, Regulatory Affairs, and Commercial Operations leadership
• Collaborate with Legal, Finance, and Corporate Development on compliance risk management, due diligence, and integration activities
• Partner with Human Resources on quality training strategy, organizational design, and change management
• Build external relationships with industry associations, regulatory agencies, and peer organizations

Qualifications

• Expert-level knowledge of global health authority regulations including FDA, EMA, PMDA, and ROW requirements for pharmaceuticals and ATMPs
• Proven expertise leading digital transformation initiatives including eQMS implementation, validation, and optimization
• Strong knowledge of Computer System Validation, data integrity, and digital compliance requirements
• Understanding of quality requirements across multiple product types (biologics, ATMPs) preferred
• Advanced expertise in quality management methodologies including Lean Six Sigma (Black Belt preferred), FMEA, Root Cause Analysis
• Proficiency with data analytics, business intelligence tools, and quality metrics dashboards
• Understanding of emerging technologies including AI/ML applications in quality, digital twins, and predictive analytics
• BS, MS, or PhD in a field of science, engineering, pharmacy, or medicine
• 15-20+ years quality leadership in Cell & Gene Therapy, biotech, or pharmaceutical industry with 10+ years managing quality systems and compliance function
• Direct experience leading multiple successful regulatory approvals and commercial launches
• Expert knowledge of FDA, EMA, and global health authority regulations
• Proven track record leading regulatory inspections
• Extensive experience implementing enterprise-wide eQMS and digital transformation initiatives
• Demonstrated success scaling quality organizations from clinical through commercial phases
• Strategic business acumen to translate quality into competitive advantage
• Ability to lead organizational transformation and drive cultural change
• Executive presence with proven ability to influence across all organizational levels
• Experience managing quality teams through high-growth environments
• Deep knowledge of ICH guidelines, 21 CFR Part 11, EU GMP Annex 11
• Strong expertise in data integrity, Computer System Validation, and digital compliance
• Advanced quality methodologies (Lean Six Sigma, FMEA, Root Cause Analysis)
• Experience with emerging technologies (AI/ML in quality, predictive analytics)