Sterile Manufacturing Program Lead

il y a 2 semaines

Brainel'Alleud, Belgique UCB Temps plein

**Make your mark for patients**

We are looking for a motivated **Sterile Manufacturing Program Lead **to join us in our Manufacturing Excellence team, in Braine.

**About the role**:
The primary objective of this role encompasses four key facets:

- Firstly, to serve as the **Business Process and Corporate Process owner** within its designated domain, he/she will continuously assess changing regulations to anticipate & drive internal updates to ensure that the UCB manufacturing site are operating under governing regulations.
- Secondly, the role is focused on cultivating collective capabilities and enhancing manufacturing performance by **leading an effective manufacturing community of practices**.
- Thirdly he/she will **act as an expert (SME)** for all activities related to sterile manufacturing and be a **key partner in ensuring successful audit or inspection** on UCB sites.
- Lastly, it aims to advance value generation and ensure uniformity by **taking charge of the cross-functional sterile manufacturing projects** spanning multiple sites and CMOs (e.g. improvement programs, product transfers.)

**Who will you work with**

Reporting directly to the Head of Manufacturing excellence, you'll collaborate with cross-functional teams, executive leadership, quality assurance/compliance teams, external partners, and lead an internal community to drive innovation and process excellence.

**What will you do?**
- ** Process ownership**:

- Review and align corporate sterility manufacturing process with new GMP requirements (RIN) to stay compliant and effective.
- Evaluate local processes against sterile corporate standards, ensuring adherence, encouraging improvement projects for compliance, maturity, and efficiency.
- Foster collaboration within the manufacturing network to develop standardized business processes and tools.
- ** Lead manufacturing community of practices**:

- Lead a sustainable expert community fostering an environment of innovation, collaboration, continuous improvement, and engagement.
- Contribute to develop the UCB sterile manufacturing capabilities by sharing benchmark, outside-in, lesson learned and drive related improvement initiatives.
- Represent the company in BioPharma related industry consortiums and coordinate associated activities.
- Identify sterile manufacturing risks and ensure implementation of risk reduction plans.
- ** Act as an expert (SME) & Be a key partner in ensuring successful audit or inspection on UCB sites**
- Offer technical guidance and support for projects, start-up activities, investigations or technical issues resolution related to both internal and external manufacturing network.
- Review and approve position papers, rationales, proposed manufacturing processes, and equipment, ensuring alignment with corporate sterile manufacturing requirements.
- Participate in site inspections and supplier audits, including being a front-line representative for inspector requests. Collaborate with the global quality team to assess compliance during internal audits and propose improvements for UCB manufacturing sites.
- Perform regular internal audit on UCB manufacturing site and propose improvements for shopfloor staff.
- ** Project leadership**:

- Lead cross-functional sterile manufacturing projects spanning multiple sites and CMOs.

**Interested? For this position you’ll need the following education, experience, and skills**:

- Master or PhD
- 10 years of relevant professional experience and a former sterile experience in BioPharma Industry.
- Confirmed practice on project leaders coaching and training.
- Knowledge of Operational Excellence, Lean et Six Sigma.
- Strong orientation toward end-to-end process performance.
- Proven experience in process definition and implementation, as well as in change management.
- Technical knowledge.
- Leadership skills.
- Ability to establish and govern manufacturing business process towards excellence performance.
- Ability to facilitate business process and monitor other members of staff towards attaining business goal.
- Ability to benchmark and analyze various business processes.
- Proficiency in a French & English.

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 for 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 or our planet. Working for us, you will discover

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