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GMDP Corporate Process Owner

Il y a 2 mois

Braine L'alleud, Belgique UCB Temps plein

 

Make your mark for patients


To strengthen our External and Clinical Supply Quality we are looking for a talented profile to fill the position of: GMDP Corporate Process Owner â Braine lâAlleud, Belgium

 

About the role

This position will serve as the Corporate Process Owner (CPO) for several Quality Systems, including but not limited to GMP/GDP/MD Deviation & Investigation and Retrain Samples. As CPO, the role is responsible for overseeing the corporate process, ensuring regulatory compliance, managing process updates and related training materials, and optimizing process efficiency. Additionally, the role will establish and maintain a cross-functional network of Subject Matter Experts (SMEs).

 

The role will also provide Quality Assurance (QA) expertise to drive both strategic and operational alignment, as well as facilitate decision-making for process adaptations and improvements tied to the relevant IT systems.

 

You will work with

Collaboration with the Transversal CPO for Deviations, Investigations, and CAPA/Effectiveness Check, along with Quality teams, Patient Supply (Development, Manufacturing, Supply Operations), and Regulatory & Safety functions, will be critical. This position is part of the External & Clinical Supply Quality organization and will work closely with colleagues who utilize these processes daily.

 

What you will do

  • Take ownership as Global Process Owner(s) of assigned Quality Systems.
  • Ensure processes are in compliance with authority regulations, leveraging the Regulatory Intelligence Network in UCB and Industry Benchmarking.
  • Specific to the GMP/GDP/MD Deviation & Investigation Process :
    • collaborate and co-create with the tCPO to any process adaptations and improvements linked to the change of regulations, IT system or continuous improvement.
    • Provide GMP/GDP/MD insights to the tCPO network as well as expertise for Corporate documentation (Policy, standard and sop).
  • Owns the documentation (UCB policy, standard & procedures) and training in English linked to the assigned processes.
  • Collaborate and co-create with the GMP/GDP QMS Lead in line with changes linked to the assigned processes owned by the CPO or cross-process topics.
  • Establish and build a network with UCB key stakeholders in relation with the assigned processes.
  • Build, establish and develop a governance model and process which fosters continuous quality process improvement and key indicator-based performance monitoring of the Quality Systems.
  • Perform the Quality Systems Management Review.
  • Maintain where possible a global approach and global process, exceptions should stay exceptions with a clear rationale agreed.
  • Work closely with Quality colleagues, Patient Supply, Regulatory, Safety & other Business stakeholders globally, site & affiliates, in an effective and efficient way.
  • Promote Best Practices throughout UCB in relation with the assigned processes.
  • Drive an active feedback culture within the organization on the assigned processes.
  • Ensure Change management across the organization, for any changes implemented on system or processes, in relation with the Quality Systems.
  • Ensure readiness for inspections, drive change management, and support audit preparation in collaboration with global auditing and compliance teams


Interested? For this position youâll need the following education, experience and skills

  • Proficiency in English is essential, while fluency in French is considered an advantage
  • Extensive knowledge of the global pharmaceutical industry, including regulatory interpretation and practical application, with a strong technical and business understanding
  • Focused on process improvement, with the ability to influence stakeholders, find common ground, and foster aligned approaches
  • Capable of working independently, handling complex situations, and making decisions that impact multiple departments
  • Skilled in analyzing data, identifying risks, and proposing solutions, demonstrating initiative and problem-solving abilities
  • Proven ability to lead and motivate matrix teams autonomously, setting and achieving challenging goals while maintaining professionalism in difficult situations
  • Effective at generating enthusiasm and commitment to strategic goals and influencing senior internal and external stakeholders
  • Experienced in managing projects globally, with strong interpersonal, communication, and leadership skills, especially at senior levels
  • Demonstrates exceptional communication skills, both verbal and written, with the ability to convey complex information clearly and effectively to diverse audiences at all organizational levels
  • Able to coach, mentor, and train colleagues, and adept at working in multicultural environments

Are you ready to âgo beyondâ 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 donât just complete tasks, we create value. We arenât 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 âgo beyondâ to create value for our patients, and always with a human focus, whether thatâs on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. 

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
 
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

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