R&D Quality Assurance Advisor – Candidate Hired

We are supporting a global pharmaceutical organisation with the appointment of an experienced R&D Quality Assurance Advisor to strengthen their Scientific Affairs and R&D QA function.

This role offers broad exposure across clinical, pharmacovigilance, and wider GxP activities, supporting both development-stage and marketed products. You’ll work closely with senior QA leadership and act as a key contributor to the organisation’s global audit strategy.

The Role

As part of the R&D Quality Assurance team, you will support and lead a range of GxP auditing and compliance activities, ensuring robust oversight of internal and external partners across the product lifecycle.

Key responsibilities include:

• Supporting the R&D QA Manager with planning, scheduling, and execution of GxP audits

• Leading audits of CROs, IACs, and third-party vendors, with wider support across other functions as required

• Acting as R&D audit process owner, helping to establish, maintain, and improve global auditing systems and ways of working

• Providing QA input into due diligence activities for new products entering the portfolio

• Offering expert QA advice to internal and external stakeholders and contributing to the development of global audit standards

• Supporting regulatory inspections and inspection readiness activities

• Advising on GxP compliance risks, deviation management, root cause analysis, and CAPA effectiveness

While the primary focus is clinical QA and pharmacovigilance, the remit also extends across wider GxP areas, including GMP oversight for IMPs and support with marketed product licence maintenance where required.

Key Requirements

You’ll be an experienced QA or auditing professional with strong exposure to GCP and/or GVP, and a genuine interest in working across the broader R&D landscape.

You will ideally bring:

• A scientific degree (Pharmacy, Chemistry, Biology, Engineering or similar), or equivalent industry experience

• Auditor certification

• 3+ years’ experience in a QA or auditing role within the pharmaceutical industry (GCP or GVP)

• Strong working knowledge of global GxP regulations and guidelines (UK, EU, FDA, ICH, WHO, PIC/S)

• A solid understanding of the drug development process and EU CTD structure

• Proven ability to critically assess technical and GxP documentation, identify risks, and propose pragmatic solutions

• Experience with vendor, CRO, and marketing partner oversight, including contractual awareness

• Excellent report writing, stakeholder management, and communication skills

• Confidence working independently while collaborating within cross-functional teams