Head of Quality Management Systems and IT Quality Compliance

Role Overview

• Responsible for leading and governing the following core elements of the Global Quality Systems Management program: Global QMS Strategy & Governance
• Define and execute the global QMS strategy, ensuring alignment with corporate Quality objectives, regulatory requirements, and business priorities
• Establish and maintain global Quality policies, standards, and frameworks as part of the enterprise QMS
• Ensure clear process ownership, governance, and accountability across all QMS elements
• Provide global oversight and accountability for key QMS processes, including: Change Control, Deviations, Investigations, and CAPA, Document and Records Management, Training and Learning Management, Quality Risk Management
• Quality Risk Management activities inducing :Quality Heatmap, Complaint Handling and Product Quality Surveillance, Data integrity
• Ensure processes are harmonized, risk‑based, and consistently applied across clusters and sites
• QMS Performance, Compliance & Inspection Readiness
• Monitor QMS performance, trends, and health metrics to proactively identify and mitigate systemic risk
• Sponsor and lead remediation and transformation initiatives to address systemic quality or compliance gaps
• QMS Modernization & Continuous Improvement
• Drive QMS simplification, standardization, and modernization through digital enablement and automation
• Own the global IT Quality Compliance framework, fully embedded within the Global QMS
• Provide enterprise governance and oversight for computerized systems validation (CSV), SDLC compliance, and data integrity
• Provide executive leadership for IT‑related audits, inspections, deviations, and critical quality events
• Act as a trusted advisor to Global Quality, IT, and business executives
• Own enterprise risk and inspection outcomes related to Quality Systems and IT Quality Compliance
• Balance regulatory rigor, operational efficiency, and innovation while maintaining Quality independence
• Provide coaching, leadership, and development to regional quality system owners and IT quality professionals.
• Lead transformation programs focused on digitization, simplification, and standardization of global processes
• Lead, mentor, and develop a high-performing global team, promoting collaboration and innovation fostering a culture of accountability, professional growth, & employee engagement.

Requirements

• BS Degree in Science, Life Sciences, Engineering, Pharmacy or related
• Minimum of 15 years’ pharmaceutical experience in a Quality or Operations role in a GMP environment in a large pharma company
• At least 5 years in leading direct reports in a site Quality unit, Quality operation, and Quality Control
• Expert knowledge and understanding of cGMP, Risk Management, and in the implementation of Pharmaceutical Quality Management Systems
• Expert knowledge in regulatory standards in Pharmaceutical Industry, including requirements and expectations of global regulatory bodies, in particular but not limited to US FDA, and EU authorities
• Critical skills/capabilities: Professional: Practical knowledge of Global Compliance and Regulatory requirements, Industry, cGxP and associated guidelines, Quality System, IT quality compliance and Risk Management. Direct interaction with health authorities
• Experience working in a large, complex matrixed environment with global processes & governance structures; practical knowledge of pharmaceuticals and R&D
• Practical knowledge on risk management.
• Essential : Strong critical thinking/problem-solving skills to navigate ambiguous situations; Strategic thinking; Excellent storytelling and presentation skills; Cross-functional collaboration and stakeholder management; Effective communication; Strong relationship and senior stakeholder management capabilities
• Leadership : Strong leadership, change management & influencing skill; Decision-making under uncertainty skills; Ability to drive transformational change in a large/global/matrixed environment; Proven talent management & people development capabilities (incl. coaching and mentoring); Ability to create an engaging & inclusive work climate and a culture of appreciation and trust; Ability to set a vision and drive organizational change and innovation; Ability to manage effectively complexity within the organization (shifting timelines, projects, priorities).

Tech Stack

• SDLC

Benefits

• generous annual leave
• reward plans
• flexible working schedules (dependent on role)
• access to tailored health support
• meaningful ways to give back to the community