Make your mark for patients
To strengthen our Internal Manufacturing Quality department we are looking for a talented profile to fill the position of: Head of QA Compliance Operations– Braine l’Alleud, Belgium
About the role
As a member of the Internal Manufacturing Quality Assurance (IMQ) Leadership team, the global position of the Head of QA Compliance Operations oversees quality compliance and process harmonization across all internal manufacturing sites and aligns with processes being followed by the External Manufacturing organization. This strategic role ensures that the quality management systems (QMS) across individual operational sites in UCB are implemented in an aligned manner and maintained continuously to meet regulatory requirements and internal standards.
The position focus will be to coordinate Global QA Oversight for Documentation and Training, IMQ Projects, Operational Excellence Initiatives, Performance (KPIs) and Quality Systems, Audit and Inspection Readiness, and lessons learned sharing and gap assessment documentation for all IM sites. While executing these Global activities, the role needs to foster a culture of continuous improvement, drive operational excellence, and collaborate with key stakeholders globally across UCB Units to uphold and enhance the organization’s quality standards.
You will work with
In this role, you will work closely with various stakeholders across UCB's internal and external manufacturing organizations. You will collaborate with the Internal Manufacturing Quality Assurance Leadership team, ensuring alignment and harmonization of quality management systems (QMS) across all operational sites. Additionally, you will engage with the External Manufacturing organization to align processes and interact with key stakeholders globally across UCB Units to foster a culture of continuous improvement and uphold the organization’s quality standards.
What you will do
* Lead a global team of quality professionals, providing mentorship, development opportunities, and support for achieving operational excellence.
* Collaborate with cross-functional teams to align quality goals with overall organizational objectives.
* Oversee the implementation and ongoing improvement of Quality Management Systems (QMS) to ensure compliance with regulatory requirements and internal governance and policies.
* Monitor and report on quality compliance metrics, using data to drive informed decision-making.
* Identify inefficiencies, gaps, and overlaps in existing quality processes.
* Drive the harmonization and standardization of quality practices across internal manufacturing sites, fostering consistency and compliance globally.
* Lead quality improvement initiatives aiming at enhancing efficiency, reducing risks, and maintaining high standards of compliance.
* Promote a culture of innovation and continuous learning within the team and across the organization.
* Ensure sites are audit-ready for internal reviews, external audits, and regulatory inspection.
* Ensure that sites are well-informed about observations from other sites that may impact them.
* Oversee the resolution of audit & inspection findings and the implementation of corrective and preventive actions (CAPA).
* Champion data integrity initiatives and oversee computerized systems validation (CSV) and automation projects to optimize manufacturing quality executions.
* Ensure compliance with global data integrity standards and best practices.
* Oversee training programs to ensure staff are well-versed in regulatory requirements, quality standards, and operational processes.
* Oversee the training matrix, onboarding, and development of quality professionals within the team.
* Serve as a primary liaison between internal manufacturing sites and corporate quality functions, facilitating effective communication and collaboration on topics related to Quality Compliance.
* Partner with key stakeholders to ensure alignment on quality strategies and objectives.
Interested? For this position you’ll need the following education, experience and skills
* Bachelor’s or master’s degree in a relevant scientific discipline.
* Minimum of 15 years in a regulated pharmaceutical environment or other life science or health-related field, including a minimum of 10 years in Quality Assurance / Quality Systems Operations.
* Fluent English communication (oral and written); any additional languages are a plus.
* Deep understanding of cGMP principles and global regulatory environments.
* Proven track record in leading teams, process optimization, and quality systems implementation.
* Experience in managing audits and inspections (FDA), including interaction with regulatory bodies.
* Excellent organizational and analytical abilities to manage complex projects and drive performance.
* Expertise with Quality Management System and Internal/External Auditing.
* Expertise with risk analysis and mitigation processes.
* Expertise in data integrity, computerized systems validation, and process automation.
* Exceptional communication and interpersonal skills for effective stakeholder engagement.
* Strategic thinking with the ability to foster a culture of Quality, Continuous Improvement and Innovation.
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 at 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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