The Global Head of Quality Systems is a senior global leadership role within the Global Quality organisation, accountable for the strategic direction, governance, and sustained effectiveness of the enterprise Quality Systems landscape. This role provides end-to-end leadership of the Quality Management System (QMS), Digital Quality Assurance (DQA), and GxP Learning & Development (L&D) functions, ensuring they collectively enable regulatory compliance, inspection readiness, operational excellence, and scalable business growth.
The role sets and executes a multi-year Quality Systems strategy aligned with corporate objectives, TOLT Strategy & direction, regulatory expectations, and industry best practices. As a key member of the Global Quality Leadership Team, the Global Head of Quality Systems acts as a strategic advisor to executive leadership, shaping how quality systems, digital capabilities, data, and people capability are leveraged to create a resilient, future-ready quality ecosystem.
Essential Functions
Strategic Leadership & Enterprise Governance
Define and own the global Quality Systems vision and multi-year roadmap, encompassing QMS, Digital QA, and GxP Learning & Development, aligned with the Global Quality and corporate strategic plans.
Provide enterprise-level leadership and oversight to ensure Quality Systems are designed, implemented, and continuously evolved to meet global GxP regulatory requirements and business needs.
Serve as the senior executive sponsor for Quality Systems governance, ensuring clear decision-making frameworks, accountability models, and cross-functional alignment.
Act as a strategic thought partner to Global Quality, Regulatory, Manufacturing, R&D, Commercial, DEC/IS, and Corporate functions on quality systems strategy, risk, and transformation initiatives.
Represent Quality Systems at executive forums, Quality Management Reviews, and other senior governance bodies.
Quality Management System (QMS) Oversight
Provide executive oversight of the global QMS, ensuring it remains compliant, fit-for-purpose, scalable, and aligned with regulatory expectations across all GxP areas.
Sponsor and govern core global quality processes including deviations, CAPA, change control, complaints, MAH oversight, quality risk management, document control, and quality metrics.
Ensure QMS performance, trends, and risks are visible to senior leadership through robust metrics, dashboards, and management review processes.
Drive continuous improvement and harmonisation of QMS processes across regions, functions, and sites.
Digital Quality Assurance & Technology Enablement
Provide strategic leadership for Digital Quality Assurance, ensuring computerized systems, digital quality platforms, and data integrity controls support compliant and efficient GxP operations.
Sponsor and oversee validation, data integrity, and digital compliance strategies for enterprise and GxP-critical systems.
Champion risk-based, pragmatic approaches to digital compliance that enable innovation while maintaining regulatory rigor.
Ensure Quality Systems strategies are fully integrated with the company’s digital, data, and automation roadmaps.
GxP Learning & Development Strategy
Set the strategic direction for global GxP Learning & Development, ensuring training governance, systems, and content effectively support compliance, inspection readiness, and organisational capability.
Sponsor enterprise-wide risk-based training models and ensure alignment between Quality Systems, business processes, and learning outcomes.
Ensure learning strategies leverage modern digital and data-driven approaches to maximise effectiveness, scalability, and employee experience.
Advocate for learning as a strategic enabler of quality culture and sustainable compliance.
Inspection Readiness, Regulatory Engagement & Risk Management
Act as a senior Quality representative during regulatory inspections, audits, and health authority interactions related to Quality Systems.
Ensure effective governance of audit findings, regulatory commitments, and systemic CAPAs related to Quality Systems.
Provide strategic oversight of due diligence & integration activities, mergers, acquisitions, and strategic partnerships as they relate to Quality Systems integration and risk.
People Leadership & Organisational Capability
Lead, coach, and develop a high-performing global leadership team across QMS, Digital QA, and GxP L&D.
Build organisational capability, succession depth, and future-ready skills within the Quality Systems function, including excellence in “quality as a service”.
Foster a culture of quality excellence, accountability, innovation, and continuous improvement.
Own functional resourcing strategies, budget oversight, and vendor partnerships across the Quality Systems organisation.
Operational Excellence & Continuous Improvement
Drive operational excellence across Quality Systems through simplification, standardisation, automation, and data-driven decision making.
Champion quality by design, risk-based thinking, and continuous improvement methodologies across the enterprise.
Ensure Quality Systems effectively support business growth, new product introductions, geographic expansion, and evolving regulatory expectations.
Required Knowledge, Skills, and Abilities
Extensive experience (typically 18+ years) in the pharmaceutical, biotechnology, or similarly regulated industry.
Significant senior leadership experience in Quality Systems, Quality Operations, or related global leadership roles.
Deep, working knowledge of global GxP regulations (GMP, GCP, GLP, GVP) and regulatory authority expectations.
Demonstrated ability to lead complex, global, matrixed organisations and influence at executive level.
Strong strategic thinking capability with the ability to translate strategy into executable roadmaps.
Proven experience leading digital, systems, and transformation initiatives within a regulated environment.
Excellent executive communication, stakeholder engagement, and decision-making skills.
Strong business acumen with the ability to balance compliance, risk, and operational efficiency.
Required/Preferred Education and Licenses
Degree in Life Sciences, Pharmacy, Engineering, or related discipline required.
Advanced degree (Master’s, PhD, MBA) preferred.
Relevant professional certifications in Quality, Risk Management, or Leadership preferred.
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