Transversal Gxp Corporate Process Owner

**Make your mark for patients**

We are looking for a Transversal GxP Process Owner able to work in highly dynamic environment to join us in our Quality Systems & Intelligence team.

About the role

Your job comprises the following main responsibilities:

- A transversal GxP Corporate Process Owner Lead role (tCPO) for Deviation Management, CAPA Management, and Investigation Management comprising a scope of multiple GxP domains and/or departments. You’ll be accountable for the process across the entire organization and across the different regulatory domains. You’ll also ensure corporate process alignment amongst regulatory domains and departments, continuous improvement/efficiency of these processes, all while ensuring process(es) are compliant with the applicable regulations.
- A CPO Governance Lead role. You’ll build, maintain and give direction to a cross-functional network of Transversal CPOs, Domain CPOs and Entity Process Owners (EPOs) where applicable, leveraging the appropriate governance to ensure the appropriate level of engagement and cross-functional consistency. This will be achieved through close working and partnering with colleagues across domains and applicable departments.

Who you’ll work with:
Reporting directly to the Head of GxP Quality Management Systems and collaborating with a cross-functional network of stakeholders, the Transversal Corporate Process Owner provides leadership and strategy to ensure the definition, development, implementation, and lifecycle management of UCB’s transversal Deviation Management, CAPA Management and Investigation Process and System and has responsibility for UCB’s Governance for Corporate Process Ownership.

What you’ll do:
Transversal GxP CPO Deviation Management, CAPA Management and Investigation
- Take ownership as Transversal Corporate Process Owner of Deviation Management, CAPA Management, and Investigation under the GXP QMS and be accountable for designing an effective and efficient process, delivering quality outcomes as required within the organization.
- Ensure that the process is clearly defined, designed, and documented (Policies and Procedures) at corporate level and across the different domains. In this regard, you’ll work closely with but also be supported by CPOs of other processes using CAPA (complaints, audits, management review), investigations (deviations, complaints, out-of-specification) and Domain CPOs (e.g., Deviations).
- Own the transversal or global documentation (UCB policy, standard & procedures) and training (if relevant) linked to the assigned Quality System Processes. You have oversight for domain documentation and training strategy with an alignment of training needs analyses.
- Provide QA expertise in driving strategic and operational Quality Assurance alignment and decision making associated to any process adaptations and improvements linked to the change of the IT system which is used for the processes owned by the tCPO. You’ll also set strategy for system and its use with domain CPOs and PDO (Process Data Owner).
- Implement a Global approach to have Global Process(es) in promoting alignment with Domain CPOs.
- Establish and build a network with Domain CPO’s and EPO’s in relation with the identified process, where applicable, leveraging the appropriate governance to ensure the appropriate level of engagement.
- Ensure transversal alignment for assigned processes across GxP disciplines (strategy for process) and departments.
- Maintain a communication plan on changes, improvements, and Best Practices. You will be accountable and perform the Quality System Monitoring Report (QSMR) for transversal CAPA Management used in the Management Review Process. Contributes to QSMRs for Deviation and Investigation issued by Domain CPOs and monitors the process performance across GxP for the assigned processes including identification of risks and areas for improvement.
- Collaborate with Quality Compliance & Auditing, to align auditor expectations & potential preparation on process specific topics for internal/external audits and inspections.
- Ensure Change management across the organization, for any changes implemented on system or process, in relation with the identified process.
- Coach professionals by providing expert advice and support in relation with the identified process.
- Build, establish, and develop a governance model and process which fosters continuous process improvement.
- Ensure that the right Key Performance Indicators are developed and used to monitor the outcome of the process, promoting the cascade of these KPIs from the QALT across the organization and across domains.
- Single Point of contact for the PDO to support update to the IT systems used for the process
- Provide inspection support to health authority inspections at UCB sites and inspections of UCB Quality Management Systems as needed to maintain UCB’s Operations in accordance with Health Authorities issued regulations and