UCB is seeking a strategic R&D and PV Vendor Quality Lead to provide expert Quality Assurance leadership on a global scale. This role drives strategic and operational QA activities for vendors engaged in preclinical (GLP), clinical (GCP), and post-marketing pharmacovigilance (GVP) work.
What You'll Do
- Participate in the assessment and qualification of Vendors supporting preclinical, clinical, and post-marketing pharmacovigilance activities.
- Provide quality input into RFI/RFP/BID processes, define evaluation criteria, and support defensible vendor selection decisions.
- Ensure handover of the qualification package to the relevant Quality Lead(s) for routine oversight after vendor qualification.
- Own and ensure Quality Agreements are in place for assigned vendors.
- Support investigations, deviations, and audit observations for assigned vendors by providing QA vendor management input.
- Define, implement, and maintain a risk-based vendor oversight model proportionate to vendor criticality and performance.
- Provide expert QA advice, support, and management for technical operational QA and general QA matters associated with vendors.
- Act as a Best Practice ambassador and lead harmonization initiatives across the company.
What We're Looking For
- Bachelor’s, master’s degree, or education in a relevant scientific discipline.
- Fluent English communication skills, both oral and written.
- A minimum of 8–10 years of proven experience in preclinical (GLP), clinical (GCP), and post-marketing pharmacovigilance (GVP), with demonstrated expertise in the practical application of relevant regulations (EMA/FDA/ICH; OECD GLP principles).
- Strong vendor lifecycle quality expertise: risk-based qualification and auditing; deviation management; CAPA lifecycle; Quality Agreement management.
- Data integrity mindset and awareness of electronic system validation considerations relevant to vendor services.
- Root cause analysis and vendor risk management skills with a continuous improvement mindset.
- Integrity and objective professional judgment; ability to operate largely independently and handle complex situations impacting multiple departments.
- Strategic thinking and foresight to anticipate risks, recommend mitigation strategies, and drive sustainable compliance and performance enhancements.
- Ability to support colleagues' professional development, share best practices, and navigate effectively in diverse, multicultural environments.
- Skill in conducting independent analysis to derive sound conclusions and informed decisions.
Nice to Have
- Proficiency in any additional languages.
- Training or formal education in Legal or Paralegal disciplines.
- Demonstrated experience with digitalization, automation, or Artificial Intelligence (AI)-driven technologies and a strong inclination toward leveraging such solutions to enhance processes.
Team & Environment
You will report directly to the Head of R&D and PV Vendor Quality. At UCB, we ‘go beyond’ to create value for our patients with a human focus, and foster a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work.
Work Mode
This is a hybrid position based in Bulle, Switzerland.
UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.
