Head of R&d and Pv Vendor Quality

il y a 4 semaines

Brainel'Alleud, Belgique UCB Temps plein

**Make your mark for patients**

To strengthen our **R&D and PV Quality** department we are looking for a talented profile to fill the position of**:Head of R&D and PV Vendor Quality - Braine l’Alleud, Belgium**

**About the role**

The Head of R&D and PV Vendor Quality will lead and advocate for quality assurance in their area of responsibility, focusing on Global Vendors involved in GLP, GCP and GVP activities. This profile will ensure compliance, risk minimization, and quality by design. This role involves setting up processes and tools for vendor qualification and contract implementation, working closely with vendor quality counterparts and UCB representatives. 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.

**You will work with**

The Head of R&D and PV Vendor Quality will collaborate closely with various stakeholders within the R&D and Pharmacovigilance Quality (RDPVQ) team. This includes working with Vendor quality counterparts, UCB functional teams, and Global Quality representatives to ensure compliance and quality assurance in GLP, GCP, and GVP activities. 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. This role is pivotal in ensuring that processes, systems, and tools are in place for vendor qualification and compliance, contributing to the successful delivery of assets and brands.

**What you will do**

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
- 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

**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 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,

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