Responsible for leading and governing the Global Quality Systems Management program
Define and execute the global QMS strategy
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
Ensure the Global QMS supports continuous inspection readiness and effective regulatory compliance
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
Drive QMS simplification, standardization, and modernization through digital enablement and automation
Lead and develop a global Quality Systems and IT Quality organization

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.
Strong critical thinking/problem-solving skills to navigate ambiguous situations
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)

Head of Global Quality Management Systems, IT Quality Compliance

Key skills