YOUR ROLE:

The Head of R&D and PV Vendor Quality will lead and advocate for quality assurance focusing on Vendors involved in outsourced GLP, GCP and GVP activities. This role is pivotal in ensuring that processes and systems are in place for vendor assessment, qualification, and for ensuring and monitoring quality from implementation through end of contract.  contributing to the successful delivery of solutions to Patients. The Head of Vendor Quality will manage a team, be part of the R&D and PV Quality Leadership Team and report directly to the Head of R&D and PV Quality.

The Head of R&D and PV Vendor Quality will collaborate closely with various external vendor organizations and internal functions which include a.o. Asset Quality Leads, Auditing and Compliance Leads, and Functional Subject Matter Experts. Additionally, the Head of R&D and PV Vendor Quality will be part of the R&D and PV Quality Leadership Team, reporting directly to the Head of R&D and PV Quality.

YOUR RESPONSIBILITY:

Leading a team of GLP, GCP, GVP Vendor Quality Leads (VQL)

• Coach, lead and empower a team of VQLs;


• Create strategic quality objectives, that focus on enabling UCB functional areas;


• Ensure the maintenance and lead the development of processes, systems and tools that are lean and fit for purpose, in support of the responsibilities and activities of VQL;


• Etablish and build a network with UCB key stakeholders in relation to the GLP, GCP and GVP compliance reference system /data integrity and ensure connections with relevant VQLs are established;


• Establish good reports with Vendor Quality counterparts and ensure regulator meetings are established aimed at ensuring compliance and data integrity during the execution of delegated activities.

Ensure compliance with GxP regulations, guidance and internal procedures while reducing complexity

• Support the UCB Vendor Strategy and design a qualification methodology that is lean, considers risks and the criticality of the activities outsourced;


• Oversight on the investigation of quality issues, audit and inspection findings pertaining to activities managed by GLP GCP GVP vendors, and the timely remediation thereof, in collaboration with Vendor Quality counterparts, relevant functions within R&D and PV Quality, and Global Quality. Facilitate quality optimization initiatives;


• Oversight on risks identified and the timely completion of mitigation activities;


• Ensure the coordination of inspection readiness and management activities, act as the central point of contact and liaison with vendors in scope of the inspection;


• Host or support inspections (e.g., inspection strategy development, management of pre-inspection documentation, quality reviews, etc.).

Monitor Performance

• Lead and conduct analytics and qualitative assessments to identify trends;


• Provide feedback to functional area heads related to Key Quality/Performance Indicators and quality compliance status;


• Monitor quality deliverables from vendors and partners, sharing updates with internal function heads.

GxP Quality Advisor

• Quality Advisor for Steering or Governance committees or councils to support and ensure oversight;


• Pro-actively Identify Opportunities to De-Risk at a Candidate/Asset/Brand Level;


• Provide expert guidance on issues escalated to support quality improvement measures;


• Review and implement updates to GxP legislations and UCB controlled documents and assess the potential impact on tasks delegated to vendors;


• Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors;


• Define best practices and assess the impact on procedures, systems and contractual arrangements;


• Deliver presentations to peers, senior management, and industry audiences by effectively communicating complex information and insights tailored to each group's specific interests and expertise.

REQUIREMENTS:

• Bachelor’s, master’s degree or an education in a relevant scientific discipline;


• A minimum of 10 years of experience working in the (bio)pharmaceutical industry preferred, with a minimum of 5 years in the research, clinical development or Pharmacovigilance domain;


• Proficient in research/GLP, GCP and/or GVP regulations;


• Ability to translate regulatory and quality expectations into operations, based on knowledge of quality principles;


• Experience in GLP, GCP and/or GVP quality auditing, inspection, compliance management, and/or Medical Device regulations/operations is an asset;


• Proficient in MS Office Suite; experience with statistical programs, SAP and Veeva is an asset;


• Ability to drive collaboration and engagement across the stakeholder network, motivating others to achieve results;


• Skilled in influencing others within a global matrix organization and driving informed decision–making;


• Capable of prioritizing and focusing on critical issues using a risk-based approach;


• Manages quality and compliance issues with diligence, rigor, transparency and timeliness;


• Strong analytical skills with experience in analyzing and synthesizing complex data;


• Proficient in presenting complex projects and issues clearly and succinctly;


• Expertise in managing transversal quality optimization projects and resolving complex issues;


• Excellent planning, organizational, presentation, training, communication, and interpersonal skills.

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.

EQUITY AND DIVERSITY:

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.