R&D Quality Manager

2 weeks ago

Slough, Slough, United Kingdom UCB S.A. Full time
Make Your Mark for Patients

To strengthen our Global Quality Assurance department, we are seeking a talented professional to fill the position of Head of Global Quality Auditing R&D and PV. This role involves formulating and implementing UCB's Global Quality Auditing strategy within the realms of Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).

About the Role

This Quality Leadership role encompasses the creation, execution, and continuous refinement of risk-based audit programs to ensure stringent compliance of UCB's systems with GVP, GCP, and GLP standards globally.

You Will Work With

In this role, the Quality Head will collaborate with an international team of internal and external auditors, overseeing multiple vendors and ensuring compliance with GVP, GCP, and GLP standards. They will work with key internal stakeholders, support Health Authority Inspections, and engage with third-party partners to drive continuous quality improvement across UCB's global operations.

What You Will Do

  • Develop and implement comprehensive GVP, GCP & GLP audit strategies that include a risk-based audit program to ensure the robustness of UCB's GVP, GCP & GLP Quality Systems.
  • Create and maintain the global audit program leveraging a risk-based approach for ranking and prioritization to generate an annual audit plan.

Audit Execution

  • Ensure regular GVP, GCP & GLP audits as outlined in the annual programs are conducted. These audits should encompass internal sites, vendors, systems, and potential new partners to ensure compliance and identify areas for improvement.
  • Drive the R&D and PV global audit program through the execution of Routine, and for Cause audits, as well as Qualification audits.
  • Ensure Due Diligence audits are conducted, as and when required, in accordance with UCB's strategy to enrich pipeline and portfolio by bringing new assets into existing and new populations.

Audit Findings Management

  • Manage all audit findings, responses, and Corrective and Preventive Actions (CAPAs) using an Audit Management Tool and escalate issues as necessary.

Data Management and Performance Tracking

  • Ensure accurate and timely audit data entry in the Audit Management Tool. Issue Key Performance Indicators (KPIs) and dashboards for trend analysis and risk assessment across the GVP, GCP & GLP quality systems.

Compliance Oversight and Quality Improvement

  • Identify and escalate GVP, GCP & GLP compliance and data integrity concerns. Provide expert guidance on CAPAs and quality improvements and report compliance risks or issues to senior leadership.

Consultation and Education

  • Use Regulatory Intelligence, Industry benchmarking, and knowledge of business, regulatory, and quality standards to influence quality approaches and ensure compliance.
  • Provide GVP, GCP & GLP compliance consulting and education to ensure that the UCB network remains current with regulatory and industry trends.
  • Lead or contribute to global quality projects and initiatives and promote internal and external collaboration to adopt new and enhance existing digital solutions.
  • Cultivate internal and external networks to maintain expert awareness of current regulatory thinking, trends, and benchmarking through key regulatory and industry relationships.
  • Foster a learning, agile, and progressive culture to work efficiently and pragmatically and promote digital innovation.

Management and Leadership

  • Lead and develop the team to achieve objectives and enhance auditor capabilities.
  • Promote a culture of risk management and continuous improvement.

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. UCB and its subsidiaries encourage diversity and inclusion in the workplace; 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.

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