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

Dublin - Ireland

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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 highquality medicines by integrating endtoend trial process excellence with proactive riskbased quality managementpowering 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 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. EndtoEnd Process Ownership & Strategy

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

2. CrossFunctional Collaboration & Process Improvement

Lead and support crossfunctional process improvement and changemanagement 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 processrelated 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

Required Experience:

Senior IC

Job Description SummaryLocations: Dublin Ireland; Westworks London UK; Barcelona SpainFull time Hybrid #LI-HybridJoin a team that is redefining how Novartis delivers highquality medicines by integrating endtoend trial process excellence with proactive riskbased quality managementpowering smarter dec...