Make your mark for patients
To strengthen our Bio DS Quality department, we are looking for a qualified candidate to fill the position of: Head of Bio DS System Quality – Braine l’Alleud, Belgium
About the role
The Bio DS System Quality Head will uphold a robust quality culture at UCB’s new commercial biologicals drug substance facility at our Braine campus. This role is vital for ensuring compliance with regulatory and internal standards, contributing to the reliable supply of drug substances, and fostering a cohesive and recognized quality team that collaborates effectively with business and other quality counterparts.
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 engaging with relevant stakeholders to ensure that the perspectives and needs of the Bio DS Quality team are represented and considered. You will actively participate in quality and business initiatives that may impact the team, spanning from operational activities to corporate and strategic levels. This engagement is essential for fostering collaboration, driving alignment, and ensuring that the Bio DS Quality team contributes effectively to broader organizational goals.
What you will do
Leadership and Management
* Guide and oversee the Quality System team, including recruitment, training, and performance oversight.
* Encourage clear communication within the Bio DS Quality team and work towards consistency.
* Develop people capability and knowledge (technical expertise, behavioral, and managerial).
* Cultivate a culture of quality, compliance, and continuous improvement within the organization.
* Ensure a safe and healthy work environment. Encourage strong participation from the Quality System team in the HSE program.
Quality Culture
* Raise awareness of regulatory and quality management systems among the Braine Bio DS staff.
* Assist with network initiatives related to quality and compliance for local implementation; act as a connection for global initiatives related to quality and compliance for local implementation (including Regulatory Intelligence Network RIN).
* Benchmark with external sources to understand industry trends and share insights with the department.
* Serve as a quality and technical advisor for the interpretation and application of regulatory and global requirements for the Braine Bio DS staff.
Quality Governance
* Ensure that adequate quality governance boards are implemented and provide direction (e.g., deviation review board, change control review board, etc.).
* Chair the Quality Council; develop relevant indicators to assess maturity levels and propose action plans to ensure continuous improvement and enhance Quality Culture.
* Clarify roles and responsibilities and interactions with other functions involved in QMS. Ensure the voice of the Bio DS Quality team is accounted for.
Regulatory Compliance
* Lead the inspection readiness program.
* Coordinate inspections or audits by regulatory authorities, UCB Global Quality Auditing team, and others as needed (including development of responses).
Continuous Improvement
* Identify opportunities for process improvements and lead initiatives to enhance quality and efficiency.
* Implement best practices and innovative solutions to improve quality and operational performance.
Assist new facility takeoff
* Build connections within the UCB organization to improve the visibility and influence of the team (e.g., quality systems & strategy, internal manufacturing quality, global quality auditing).
Interested? For this position, you’ll need the following education, experience, and skills
* Bachelor’s, master’s degree, or an education in a relevant scientific discipline.
* A minimum of 10 years of extensive experience in the pharmaceutical industry, showcasing a deep understanding of industry standards and practices.
* Good proficiency in French and English, enabling clear and effective communication in both languages.
* Proven expertise in quality systems and quality compliance, with a strong track record of ensuring adherence to regulatory requirements and internal protocols.
* Significant experience in conducting audits and inspections, demonstrating the ability to identify and address compliance issues effectively.
* Strong teamwork skills, with the ability to work seamlessly across various departments and hierarchical levels, encouraging and motivating others to achieve common goals.
* A commitment to maintaining an on-site presence, ensuring hands-on leadership and direct engagement with team members and operations.
* 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.
* Proficiency with Veeva systems is beneficial.
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.
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