Transversal Gxp Corporate Process Owner
Il y a 4 mois
**Make your mark for patients**
To strengthen our **Quality Systems & Strategy Department** we are looking for a talented person to fill the position of: Transversal GXP Corporate Process Owner - Braine l’Alleud, Belgium
**About the role**
The **Transversal GXP Corporate Process Owner (CPO)** provides management and strategy to ensure the definition, development, implementation and lifecycle management of UCB’s transversal Inspection Readiness and Management Process and related System.
**You will work with**
As a Transversal GXP CPO you are responsible for overseeing Inspection Readiness and Management process within the GXP Quality Management System. You will collaborate with domain CPOs, entity process owners(EPO), and various stakeholders across departments to ensure alignment, compliance and continuous improvement in inspection-related processes. Additionally, you will work with IT stakeholders to translate users’ requirements into IT system functionalities supporting the inspection process.
**What you will do**
- Responsible for owning the Inspection Readiness and Management process within the GXP QMS
- Work closely with Domain CPOs and EPOs to align on Inspection Readiness and Management processes
- Ensure that the Inspection Readiness and Management process is clearly defined, designed, and documented (Policies and Procedures) at corporate level and across the different domains
- Promotes best practices and maintains communication on changes and improvements
- Ensures clear definition, design, and documentation of the Inspection Readiness process
- Performs Quality System Monitoring Report (QSMR) for Inspection Readiness
- Ensures compliance with authority regulations and industry benchmarks
- Acts as a point of contact for Regulatory Intelligence related to Inspection Readiness
- Collaborates with stakeholders to align expectations & potential preparation on process specific topics for internal/external audits and inspections.
- Supports validation and migration activities related to IT systems
- Builds, establishes, and develops a governance model and process which fosters continuous process improvement
- Participates in UCB Quality Councils on Inspection related topics
- Authors, reviews, or approves SOPs, deviations, change controls, CAPAs, and investigations related to Inspection Readiness
**Interested? For this position you’ll need the following education, experience and skills**
- Preferably a Master’s degree
- Demonstrate excellent communication skills in English, with proficiency in French being an additional asset
- Excellent stakeholders management capabilities and negotiation/influencing skills
- Profound understanding of global GxP and Medical Device regulations
- 5 years of experience in preparing for and managing Regulatory Authority Inspections (FDA, EMEA, MHRA )
- Foster a quality culture of shared accountability and knowledge sharing through inspiring, motivating, influencing, teaching and coaching others
- Backs change initiatives for value creation and promotes a technology-motivated mindset
- Must have a process improvement mindset, able to influence different stakeholders, find common ground and bring stakeholders closer together with aligned approach
- Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments
- Must have ability to identify risks and propose corrective actions within areas of expertise. Also demonstrates initiative and the ability to help others solve problems in a creative and practical way
- Must have the ability to manage projects or activities across global geographies within the area of expertise. Be capable of guiding and motivating teams and demonstrate professional maturity in difficult situations. Set stimulating objectives for self and others and drive for results
- IT skills to effectively understand and communicate with the IT department to improve system requirements
- Experience with Veeva platform is a great asset
If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB.
RANDATUCB
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
**About us**
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
**Why work with us?**
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees,
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