R&D and PV Vendor Quality Lead (Switzerland)

Make your mark for patients

To strengthen our R&D and PV Vendor Qualitydepartmentwe are looking for a talented profile to fill the position of:R&D and PV Vendor Quality Lead Bulle Switzerland

About the role

This position provides leadership and in-depth Quality Assurance (QA) expertise to drive strategic and operational QA activities associated with Vendors engaged in preclinical (GLP) clinical (GCP) and post-marketing pharmacovigilance (GVP) activities relating to Sponsor and/or MAH obligations on a global Vendor Quality Lead (VQL) reports to the Head of R&D and PV Vendor Quality and takes responsibility for the activities for the vendors assigned ensuring inspection readiness robust contractual language (e.g. Quality Agreements) risk-based oversight and sustainable vendor performance.

You will work with

The role ensures end-to-end vendor quality governance across the vendor lifecycle (selection qualification oversight performance improvement and transition/termination). This will be achieved through close partnering with Global QA management within UCB Quality Leads focusing on preclinical (GLP) clinical (GCP) and post-marketing (GVP) compliance GMP/GDP Vendor Quality Leads for vendors operating in the interface Corporate Process Owners Procurement Legal Digital/IT and other internal UCB Teams and stakeholders delegating activities to selected Vendors and through direct engagement with vendor organizations (vendor QA and operational leadership) to drive governance performance improvements and inspection readiness.

What you will do

• Participatein the assessment and qualification of Vendors supporting preclinical (including but not limited to GLP) clinical (GCP) and/or post-marketing pharmacovigilance (GVP) activities (including Digital/IT andeClinicalvendors whereGxPapplicable).
• Provide quality input into RFI/RFP/BID processes including defining evaluation criteria contributing to scoring and supporting defensible vendor selection decisions.
• After vendor qualification ensure handover of the qualification package (incl. system/data integrity expectations/evidence) to the relevant QL(s) for routine oversight coordinating with IT/CSV (validation execution) to confirm validation readiness/go-live evidence; for any new or materially changedGxP-relevant system introduced later ensure documented handover of implementation/go-live evidence with agreed monitoring points escalation pathways and periodic review
• Ensure Quality Agreements are in place and take ownership of agreements for the vendors assigned (creation support negotiation input periodic review updateclosureand archiving). Ensure post-marketing GVP responsibilities and governance expectations are explicit (e.g. escalation timelines data exchange subcontractor controls record retention audit rights).
• Support the Deviation & Escalation team (lead contact) by providing QAvendor managementinput for investigations deviations and audit observations associated with assigned vendors.
• Defineimplementandmaintaina risk-based vendor oversight model proportionate to vendor criticality and performance;establishgovernance cadence meetingstructuresand escalation pathways.
• Provideexpert QA advice support and management for technical operational QA and general QA matters associated with vendors; work closely with Corporate QA teams functionalareasand affiliates across geographies.
• Be aBest Practice ambassador and lead best practice/harmonization initiativesacross the company as assigned.

Interested For this position youll need the following education experience and skills

• Bachelors masters degree or an education in a relevant scientific discipline
• Fluent English communication (oral and written); any additional languages are a plus.
• Training or formal education in Legal or Paralegal disciplines would be an advantage for this role.
• A minimum of 810 years of proven experience in preclinical (GLP) clinical (GCP) and post-marketing pharmacovigilance (GVP) with demonstrated expertise in the practical application of relevant regulations and guidelines (EMA/FDA/ICH; OECD GLP principles as applicable).

• Strong vendor lifecycle quality expertise: risk-based qualification and auditing/assessment planning & execution; deviation management; CAPA lifecycle and verification of effectiveness; Quality Agreement lifecycle management.
• Data integrity mindset and awareness of electronic system validation considerations relevant to vendor services including GxP-relevant Digital/IT platforms and eClinical systems where applicable.
• Demonstrated experience with digitalization/automation/Artificial Intelligence-driven (AI) technologies and a strong inclination toward leveraging such technological solutions to enhance processes and decision-making is a great asset
• Root cause analysis and vendor risk management/assessment skills; continuous improvement mindset (lean/process mapping/workflow optimization).
• Integrity and objective professional judgment; operates largely independently and handles complex/difficult situations impacting multiple departments.
• Demonstrates strategic thinking and foresight by anticipating potential risks recommending practical mitigation strategies and driving sustainable compliance and performance enhancements.
• Actively supports the professional development of colleagues by sharing best practices and contributing to the cultivation of top talent; navigates effectively in diverse multicultural environments.
• Conducts independent analysis to derive sound conclusions and informed decisions; identifies risks and recommends appropriate corrective or preventive actions within their area of expertise.

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 over 9.000 people in all four corners of the globe inspired by patients and driven by science.

Why work with us
At UCB we dont just complete tasks we create value. We arent 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 equal opportunities to do their best work. We go beyond to create value for our patients and always with a human focus whether thats 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.

At UCB weve embraced a hybrid-first approach to work bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.