Make your mark for patients
To strengthen our Quality Management & Strategy department we are looking for a talented profile to fill the position of: Corporate Process Owner – Braine l’Alleud, Belgium.
About the role
You will be reporting directly to the Head of Quality Performance and Process, the 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.
You will work with
As a CPO you will build, maintain, and give direction to a cross-functional network of 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.
What you will do
1. Take ownership as Corporate Process Owner of Deviation Management, CAPA Management, and Investigation under the GXP QMS. Accountable for designing an effective and compliant process, delivering quality outcomes as required within the organization.
2. Ensure that the process is clearly defined, designed, and documented (Policies and Procedures) at corporate level and across the different GxP domains. Works for this closely with and is supported by CPOs of other processes using CAPA management (complaints, audits, management review), investigations (deviations, complaints, out-of-specification) and Domain CPOs (e.g., Deviations).
3. Own the corporate documentation (UCB policy, standard & procedures) and training (if relevant) in English linked to the assigned Quality System Processes. Has oversight for domain documentation and training strategy with an alignment of training needs analyses.
4. The position provides 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 CPO. Sets strategy for system and its use with domain CPOs and Process Data Owner (PDO).
5. Implement a Global approach to have Global Process(es) in promoting alignment with Domain CPOs.
6. Ensure transversal alignment for assigned processes across GxP disciplines (strategy for process) and departments. Works closely/collaborate with Process stakeholders (including Domain CPO’s, Domain QMS Leads, and PDO) in an effective and efficient way.Drives an active feedback culture within the organization on the identified processes.Promotes Best Practices throughout UCB in relation with the identified processes.
7. Collaborates with Quality Compliance & Auditing, to align auditor expectations & potential preparation on process specific topics for internal/external audits and inspections.
8. Ensure the process is compliant with authority regulations, leveraging the Regulatory Intelligence Network in UCB and Industry Benchmarking
9. Ensures Change management across the organization, for any changes implemented on system or process, in relation with the identified process.
10. Coaches professionals by providing expert advice and support in relation with the identified process.
11. Builds, establishes, and develops a governance model and process which fosters continuous process improvement.
CPO Governance Lead
12. Builds, establishes, and maintains a governance model which fosters a cohesive cross-departmental network of CPOs, Domain CPOs and EPOs.
13. Establishes and maintains an approved and up-to-date list of CPOs, Domain CPOs and EPOs for the UCB organization as a core element of inspection readiness.
14. Maintains generic job descriptions for CPO and Domain CPO roles and CPO related training packages up to date.
Interested? For this position you’ll need the following education, experience and skills
15. Master’s degree in relevant scientific discipline
16. Fluent English communication (oral and written); any additional languages are a plus.
17. Minimum 7 years of experience in pharmaceutical industry with minimum of 3 years’ experience in pharmaceutical operation (preferably production or QA)
18. A good and thorough understanding of current regulatory GxP requirements and expectations (e.g., U.S., Europe, Japan, China) and an ability to interpret current regulations and requirements in product development and commercial manufacturing and distribution context is essential.
19. Ability to evaluate quality management systems and quality operations independently and critically in support of Quality culture and operational output, balancing weaknesses against requirements and expectations.
20. Foster a quality culture of shared accountability and knowledge sharing through inspiring, motivating, influencing, teaching, and coaching others.
21. Ability to influence different stakeholders, find common ground and bring stakeholders closer together with aligned approach.
22. Strong knowledge on Root Cause Analysis: Various technic on root cause analysis (5 whys, fish bone = 6 M, etc) and demonstrate its usage
23. Strong knowledge on CAPA & EC (SMART principles)
24. Capacity to focus on details such as process design or procedure writing and zoom out and think at a strategic level for its process (prioritize improvement and what is valuable).
25. Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally.
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!