QA Downstream Manager

il y a 3 semaines

Brainel'Alleud, Wallonie, Belgique UCB Temps plein

Make your mark for patients

We're in search of a Quality Downstream Manager with excellent communication skills, agile and a readiness to face challenges to join our Quality Department team, based in Braine-l'Alleud, Belgium, and play a pivotal role in our brand new Biomanufacturing plant.

About the Role:

In this vital position, you'll:

  • Be instrumental in the facility startup, ensuring agility, proactivity, and clear accountability for all quality aspects related to Downstream manufacturing activities.
  • Manage both short-term and long-term Downstream quality oversight, from technology transfers and validations to ensuring compliance with cGMP Regulations.
  • Develop your team, fostering career growth, and build concerted relationships across departments.

Who You'll Work With:

Quality Assurance Teams: work closely with Quality Assurance teams to ensure compliance and address quality issues promptly.

Production Teams: Partner with production teams, providing quality oversight and Support for Downstream manufacturing operations.

Compliance Teams: Work alongside compliance teams to ensure all manufacturing activities meet regulatory standards.

Corporate Quality Partners: Build trustful and Collaborative relationships with corporate quality partners, contributing to the overall quality strategy and initiatives.

Key Responsibilities:

Short-term Activities:

  • Actively participate in Downstream technological transfer teams.
  • Ensure Downstream manufacturing activities' validations are in line with cGMP Regulations.
  • Lead GMP certification inspections for your area.
  • Provide GMP authorization for the start of manufacturing activities after ensuring all prerequisites for critical milestones are met.

Medium to Long-term Activities:

  • Oversee the quality of Downstream manufacturing operations daily.
  • Manage quality for Downstream manufacturing-related activities, including Qualification and Validation, Vendors Change Notification, etc.
  • Conduct efficient and accurate batch review processes and release Process Orders related to Downstream manufacturing activities.
  • Maintain quality systems within your scope, monitor quality performance with relevant KPIs, and promote Quality on the Shop Floor culture.
  • Direct actions in answer to manufacturing incidents affecting quality or compliance, ensuring thorough investigations and adherence to escalation mechanisms.
  • Supervise daily departmental activities, ensuring alignment with Quality assurance peers and fostering a reliable partnership with local and global business partners.

Interested? We're looking for someone with:

  • A master's degree in a relevant field is preferred
  • 5 years or more of experience in the pharmaceutical industry within manufacturing operations, focusing on sterile or biological products, preferably within Downstream manufacturing operations.
  • Deep comprehension of cGMP for biological products.
  • Agility and adaptability in a dynamic environment.
  • Strong communication skills and a team player mindset.
  • Solutions oriented
  • Fluency in English. French is a strong asset.

To know more about our biotech activities visit our biomanufacturing career site

#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 on EMEA- Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

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