Senior Global Process Owner, PRS

Overview

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Locations : Dublin, Ireland; Barcelona, Spain or Westworks, London, UK

Full time, Hybrid.

Role Summary

The Senior Global Process Owner (Sr. GPO) is accountable for designing and managing an end-to-end business process that is compliant with regulatory requirements and fulfills business needs across the end-to-end trial process in Development. The Sr GPO is responsible for overall governance and oversight of a process by setting strategy, coordinating process mapping activities, overseeing development of procedural documents, ensuring efficiency and effectiveness of the process, and managing risks. The role also monitors process performance via KPIs / KQIs aligned with regulatory and organizational strategies.

The role acts as a single point of ownership that drives process health and continuous improvement for sustained process maturity. It drives adoption by collaborating with Global Line Functions within a complex matrix, ensuring processes meet high design standards, regulatory compliance, and practicality. Promotes simplification and process automation. The specific domain for this role is study feasibility and start up, and regulatory green light (in particular, demonstrated expertise in FDA 21 CFR and EU CTR); hands-on CTIS experience is highly desired. Accountable for end-to-end delivery, maintenance and improvement of the designated process(es).

Responsibilities

• Act as point of contact for the Quality System Owner (QSO) for process-related queries or tasks, and for the Line Function Representative.
• Lead the design and management of streamlined processes within functional and cross-functional settings.
• Coordinate process mapping activities executed by Business Process Excellence Experts.
• Ensure oversight of controlled documents (SOPs and Working Practices) of the designated process.
• Serve as point of contact for the author (Lead SMEs) of controlled documents to ensure consistent document lifecycle management.
• Provide guidance to authoring teams on the content of procedural documents.
• Ensure coherence between activities surrounding a defined process and its controlled documents with regulatory compliance checks and controls.
• Drive harmonization and simplification of processes across different controlled documents.
• Support QSO in monitoring and analyzing the impact of regulatory changes related to owned procedures (including digitization of the QMS).
• Monitor and analyze the impact of other procedural changes on own procedures.
• Lead cross-functional process improvement and change management activities to optimize and strengthen operations.
• Ensure new and transformed business processes can be delivered globally and by the responsible parties, e.g., Global Line Functions.
• Contribute to training strategy for the process; design, develop and maintain metrics with Global Line Functions and Compliance & Quality where relevant. Monitor KPIs and KQIs, assess deviation trends; be SPOC for audits and inspections as relevant to scope.
• Oversee risks related to the designated process and participate in Annual QS review under the direction of the QSO. Conduct root cause analyses and / or FMEAs and develop CAPAs as required, measuring CAPA effectiveness.

Education and Qualifications

Education (minimum / desirable)

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

Languages

Relevant Experiences

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