Senior Process Quality Excellence Specialist CV-Library Senior Process Quality Excellence Specialist

Scienceabode; Slough, City of London, Reading, Oxford; On-site; GBP 69,000 - 80,000; Full time

Job summary

A global biopharmaceutical organisation is seeking an experienced Quality professional in Slough to enhance their Process Quality Excellence team. The role will involve supporting quality system maintenance, developing policies and SOPs, and ensuring compliance with GCP and regulatory standards. Ideal candidates will have over 8 years of experience in the pharmaceutical sector, especially in QA or Clinical Development. Competitive salary range is £69,000 – £80,000 per annum.

Qualifications

• 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.

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.
• Leading and coordinating inspection readiness across all clinical operation functions.

Skills

Quality assurance

GCP

Regulatory compliance

SOP writing

Audit management

Job description

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

£69000 – £80000/annum