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

Job Description Summary

Locations: Dublin, Ireland; Westworks, London, UK; Barcelona, Spain
Full time, Hybrid, #LI-Hybrid
Join a team that is redefining how Novartis delivers high‑quality medicines by integrating end‑to‑end trial process excellence with proactive, risk‑based quality management—powering smarter decisions, stronger data integrity, and faster impact for patients worldwide
The Senior Global Process Owner (Sr. GPO) - Risk-based Quality Management (RBQM) is accountable for designing and managing an end-to-end business process that is compliant with regulatory requirements and is fulfilling business needs across the end-to-end trial process in Development. The Sr GPO will be responsible for overall governance and oversight of a process by setting appropriate strategy, coordinating process mapping activities, overseeing the development the various procedural documents related to a process, ensuring efficiency and effectiveness of the process and managing risks. In addition, the Sr GPO would also be responsible to monitor process performance via KPIs/KQIs aligned with regulatory and organizational strategies.

 

Job Description

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.

 

Skills Desired

Clinical Site Management, Clinical Trial Development, Clinical Trial Management, Clinical Trial Process, Clinical Trials, Global Drug Development, Pharmaceutical Industry, Process Ownership, Risk Based Monitoring, risk based quality management, Risk Monitoring, Study Management