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Senior Global Process Owner, PRS

Senior Global Process Owner, PRS

NovartisCity Of London, England, United Kingdom
8 days ago
Job type
  • Full-time
Job description

Join to apply for the Senior Global Process Owner, PRS role at Novartis

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

Full time, Hybrid

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 will be responsible for overall governance and oversight of a process by setting strategy, coordinating process mapping activities, overseeing the development of procedural documents related to a process, ensuring efficiency and effectiveness of the process and managing risks. The Sr GPO will monitor process performance via KPIs / KQIs aligned with regulatory and organizational strategies.

About The Role

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 collaborating with Global Line Functions within a complex matrix, ensuring that processes meet 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 the end-to-end delivery, maintenance and improvement of the designated process(es).

  • Act as point of contact for the Quality System Owner (QSO) for any process-related queries or tasks, as well as 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.
  • Act as point of contact for the author (Lead SMEs) of controlled documents to ensure consistent document lifecycle management within a process.
  • Provide guidance to authoring teams on the content of procedural documents related to the process.
  • Ensure coherence between activities surrounding a defined process and its controlled documents through robust checks and controls to ensure regulatory compliance.
  • Drive harmonization and simplification of processes across different controlled documents within the process.
  • 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 overall operations.
  • Ensure new and transformed business processes and activities are aligned and can be delivered globally and functionally by the responsible parties (e.g., Global Line Functions).
  • Input into training strategy of the process, design, develop and maintain metrics in collaboration with Global Line Functions, Compliance & Quality, when relevant. Monitor KPI and KQI, assess deviation trends. Serve as SPOC for audits and inspections as relevant to scope. Responsible for oversight and management of risks related to the designated process.
  • Participate in Annual QS review under the direction of the QSO. Conduct root cause analyses and / or FMEAs as applicable and develop CAPAs in alignment with the Lead SME. Develop CAPAs and measure CAPA effectiveness for deviations / quality incidents, audit and inspection findings pertaining to the owned process.

Education and Qualifications

Education (minimum / desirable)

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

Languages

  • Proficiency in English (read / write / speak)

    • Relevant Experiences

  • Extensive knowledge of end-to-end processes within clinical development, including supporting systems, regulations, and awareness of business changes.
  • Study Start-up, feasibility and clinical trial application (CTA) experience (min 1-2 years); hands-on CTIS experience highly desirable.
  • Demonstrated EU CTR and FDA 21 CFR knowledge required.
  • Ability to anticipate and assess the impact of external and internal changes on the end-to-end process, supporting systems (and vice-versa), and training requirements.
  • Experience in defining metrics to effectively monitor and improve processes.
  • 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 across functions, supporting performance improvements within the end-to-end clinical development value chain.

    • Benefits and other company information : Not included in this refinement.

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