Senior Global Process Owner - Risk-Based Quality Management (Clinical Trials)

The role acts as a single point of ownership that drives process health and continuous improvement for sustained process maturity. The role drives adoption by working collaboratively with Global Line Functions, within a complex matrix, ensuring that processes meet both high design standards, regulatory compliance, and high levels of practicality. Promotes simplification and process automation.

Major accountabilities:

1. End‑to‑End Process Ownership & Strategy

• Accountable for the overall design, delivery, maintenance, and continuous improvement of the designated process(es).
• Lead long‑term process strategy, ensuring alignment with regulatory expectations and business needs.
• Anticipate internal/external changes and assess their impact on processes and supporting systems.

2. Cross‑Functional Collaboration & Process Improvement

• Lead and support cross‑functional process improvement and change‑management initiatives.
• Drive simplification, automation, and standardization across functions.
• Ensure transformed processes can be executed globally by responsible line functions.

3. Governance, Documentation Oversight & Compliance

• Ensure oversight and lifecycle management of controlled documents (SOPs, WPs, manuals) for the process.

• Ensure coherence and harmonization across procedural documents within the process.
• Oversee process‑related risks and ensure appropriate mitigation strategies.
• Monitor performance trends, conduct root cause analysis/FMEAs when needed, and ensure appropriate risk management.

Minimum Requirements:
Education

Minimum: University degree in Life Science, quantitative science or business. Desirable qualifications in shared services, outsourcing, global sourcing. project management/Coaching, 6-Sigma, Lean education/training, Master of Business Administration or equivalent

Work Experience:

• Extensive knowledge of end-to-end processes within clinical development, including supporting systems, regulations, and awareness of business changes.
• Risk-based Quality Management process design and/or implementation essential
• 5 years Clinical Development or Clinical Operations experience, with a strong understanding of the clinical trial lifecycle.
• Ability to anticipate and assess the impact of external and internal changes on the end-to-end process, supporting systems (and vice-versa), and associated training requirements.
• Experience in effective process improvement.
• Strategic thinker with the ability to contribute to long-term process improvements and operational planning.
• Experience with process simplification and optimization, including improvements to quality documentation.
• Demonstrated ability to collaborate effectively across functions, supporting performance improvements within the end-to-end clinical development value chain.