Senior Process Quality Excellence Specialist
Posted 1 day ago by VRS-UK
£80,000 Per year
Undetermined
Undetermined
Slough, Berkshire
Summary: This role is for a Senior Process Quality Excellence Specialist at a global biopharmaceutical organization, focusing on maintaining high-quality systems in clinical operations. The position involves collaboration with various stakeholders to ensure compliance with GCP, GLP, and PV standards while supporting the development of quality policies and procedures. The candidate will also lead inspection readiness efforts and participate in audits and inspections. This is a 12-month contract position requiring extensive experience in the pharmaceutical sector.
Key Responsibilities:
- Supporting the Head of Process Quality Excellence in building and maintaining the clinical operation’s quality and compliance framework.
- Creating and revising quality policies, SOPs, processes, and guidance.
- Working with Global Quality, Patient Safety, Regulatory Affairs, external partners, and wider stakeholders to maintain compliance with ICH GCP, GLP, PV and relevant global/local regulations.
- Leading and coordinating inspection readiness across all clinical operation functions.
- Taking part in audit and inspection planning alongside Global Quality.
- Representing, or ensuring representation for, clinical operations during internal and external audits/inspections.
- Supporting teams with audit and inspection responses, including CAPAs and follow-up actions.
Key Skills:
- 8+ years’ experience in the pharmaceutical sector, ideally within global QA or Clinical Development.
- Strong working knowledge of GCP and GVP, with hands-on experience of global audits and/or inspections.
- At least two years’ experience writing SOPs.
- Strong experience of conducting Regulatory Intelligence.
- A proactive, solutions-focused approach and the confidence to work cross-functionally.
Salary (Rate): £80,000/year
City: Slough
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
A global biopharmaceutical organisation are looking for an experienced Quality professional as they expand their Process Quality Excellence team!
This role sits at the heart of clinical quality, helping to shape and maintain high-quality systems across global clinical operations and ensuring teams stay inspection-ready and fully aligned with GCP, GLP, and PV expectations.
You’ll work closely with the Head of Process Quality Excellence, supporting the development of policies, SOPs, and best practices, while also helping colleagues navigate quality, compliance, and regulatory requirements across clinical programmes.
What you’ll be doing
- Supporting the Head of Process Quality Excellence in building and maintaining the clinical operation’s quality and compliance framework.
- Creating and revising quality policies, SOPs, processes, and guidance.
- Working with Global Quality, Patient Safety, Regulatory Affairs, external partners, and wider stakeholders to maintain compliance with ICH GCP, GLP, PV and relevant global/local regulations.
- Leading and coordinating inspection readiness across all clinical operation functions.
- Taking part in audit and inspection planning alongside Global Quality.
- Representing, or ensuring representation for, clinical operations during internal and external audits/inspections.
- Supporting teams with audit and inspection responses, including CAPAs and follow-up actions.
What you’ll bring
- 8+ years’ experience in the pharmaceutical sector, ideally within global QA or Clinical Development.
- Strong working knowledge of GCP and GVP, with hands-on experience of global audits and/or inspections.
- At least two years’ experience writing SOPs.
- Strong experience of conducting Regulatory Intelligence
- A proactive, solutions-focused approach and the confidence to work cross-functionally.
This role is offered on an initial 12 month contract.
Keywords: quality assurance, good clinical practice, GCP, clinical trials, pharmaceutical, biotechnology, regulatory, CAPA, audit, Slough, London, Reading, Oxford, VRS9211SE