USP Bio DS Operations Quality Manager

작업 내용

To strengthen ourBIO DS Qualitydepartment, we are looking for a qualified candidate to fill the position of: USP Bio DS Operations Quality Manager – Braine l’Alleud, Belgium

About The Role

The USP Bio DS Operations Quality Manager will oversee the quality of upstream (USP) manufacturing operations at UCB’s new commercial biologicals drug substance facility on our Braine campus. Additionally, the manager will ensure the timely release of USP batches, all while promoting a solution-oriented mindset. As this is a new facility, the role requires actively guiding and training the team through the launch phase, adapting to the challenges and realities of the initial years of operation.

You will work with

This role involves establishing and cultivating strong connections with peers across both business and quality functions within the B7 and UCB organizations. It is vital for ensuring compliance with regulatory and internal standards, maintaining a continuous presence of the USP quality team on the floor, and fostering adherence to quality systems (Deviation, CAPA, CC).

What You Will Do

Leadership and Management

• Guide and oversee the USP Quality Operations team, including recruitment, training, and performance oversight
• Develop people capability and knowledge, for example, by implementing training matrices and training GMP Facilitators
• Ensure day-to-day quality oversight of the USP manufacturing operations by USP GMP Facilitators.
• Provide continuous feedback within the Quality Operations team and with Manufacturing counterparts
• Participate in the Bio DS Quality Operations Lead Team and act as deputy for the Bio DS Quality Operations Head when needed.
• Participate in regular alignment meetings with local and global business partners (i.e., Manufacturing, MSAT, Quality Assurance Support, Quality Control, Regulatory).
• Propose solutions for major and critical issues encountered in USP manufacturing.

Quality Assurance

• Responsible for the effective management of quality systems operating in the USP scope, including deviations (events), CAPA, batch review, change control, documentation, etc. Ensure these are appropriately assessed from a quality perspective and closed in time.
• Responsible for the effective and right-first-time USP batch review process and USP intermediate batch release process.
• Ensure all Process Orders (POs) related to USP manufacturing activities are released.
• Organize thorough reviews and approvals of GMP documentation and their appropriate application (e.g., gembas, spot checks, shop floor).
• Ensure quality representatives are involved in case of significant events occurring during USP manufacturing activities.
• Review and approve major or critical deviations, CAPA, and Change Control.

Regulatory Compliance

• Perform internal inspections related to USP activities.
• Assist and/or explain topics related to USP activities if requested during an internal or external inspection.
• Ensure critical/major risks related to inspection readiness for USP activities are appropriately escalated. Ensure relevant mitigations and documentation are available (e.g., PowerPoint presentations, preventive actions).

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

• Master’s degree, or an education in a relevant scientific discipline.
• Bilingual proficiency in French and English, enabling clear and effective communication in both languages.
• Minimum of 5 years’ experience in the pharmaceutical industry
• Demonstrated experience in Upstream Biologicals drug substance operations (business and/or quality).
• Proven track record in management, showcasing the ability to guide teams effectively and promote organizational success.
• Strong teamwork skills, with the ability to work seamlessly across various departments and hierarchical levels, encouraging and motivating others to achieve common goals.
• Commitment to maintaining an on-site presence, ensuring hands-on leadership and direct engagement with team members and operations.
• Experience in conducting audits and inspections, ensuring compliance with regulatory standards and internal protocols.
• Proven ability to navigate and thrive in unstable environments, demonstrating agility and adaptability in handling unforeseen changes and challenges.
• Exceptional stress resilience, maintaining composure and effectiveness under pressure to deliver consistent results.

#biomanufacturing

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, 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.