Cmc Km Lead

il y a 3 jours

Brainel'Alleud, Belgique UCB S.A. Temps plein

**Make your mark for patients.**

We’re here because we want to build the future and transform patients’ lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?

To strengthen our Knowledge Management Center of Expertise, we are looking for a senior, self-motivated, CMC Product KM Lead based in Braine l’Alleud, Belgium

At UCB everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” We do that by connecting our ground-breaking science with patients and their families around the world living with the physical and social burdens of autoimmune and neurological disorders. Those connections offer new perspectives, drive innovation, and offer the hope of a new generation of therapies that will help improve lives on a global scale.

You like to work in an environment where you can:
In the scope of the Center of Expertise Knowledge Management (CoE KM,) the CMC Product KM Lead main responsibility is to focus on the overall Product Knowledge Management for designated product(s).

The primary purposes of his/her role are:

- Point of contact regarding the product within CoE KM team.
- Drives KM activities aiming to capitalize Product knowledge for improved decision making.
- Ensure critical Knowledge risk management for the Product.
- Provide governance and best practices on critical Knowledge Management security and sustainability.
- Drives/promotes the CMC Product Knowledge Management strategy for commercial or product in development.
- KM Change agent: On-board, Coach and Train TST Members / Stakeholders to improve KM principles and best practices adoption (ICHQ10 & ICHQ12).
- Assess S&TS Knowledge package quality and integrity: knowledge being complete, accurate, consistent, and in context.
- Coordination of external Knowledge (documentation and data) Management related to Product and process development activities.
- Supports the KM strategy roll-out, to ensure a robust LCM of Knowledge Management Governance.

Interested? For this position you’ll need the following education, experience and skills:
Knowledge/Expertise/Skills
- KM expert with strong experience (10 years+) in the development and manufacturing of Biological or pharmaceutical products
- Knowledge and expertise in Medical Devices, In vitro diagnostic and Gene therapy is a plus
- Proven project leadership skills including planning, monitoring, issue resolution, decision making and reporting
- Good understanding of all disciplines related to CMC from early-stage development to commercial products. Understand GMP, Regulatory Affairs and Quality requirements
- Communication: high quality interpersonal skills, strong communication and networking skills in both French & English
- Strong organizational skills are required: ability to prioritize actions and manage multiple activities in parallel
- Leadership: ability to listen, lead, motivate and support people, and manage by influence in a complex matrix environment
- Customer and Solution-oriented, innovative & creative
- Strong sense of accountability and responsibility
- Presentation and meeting facilitation skills
- Change management skills
- Problem solving with a view to overall strategy.

**About us.**

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.

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.

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