Senior Process Quality Excellence Specialist

Job description

Senior Process Quality Excellence Specialist

Location: Slough/Remote (hybrid working)

Duration: 12 months initial (temporary role)

Rate (circa): £35 per hour (PAYE) / £47 per hour (Umbrella)

About the Role:

We are supporting a global pharma company who are seeking an experienced Senior Process Quality Excellence Specialist to support the development, maintenance, and continuous improvement of clinical quality systems within Global Clinical Sciences & Operations (GCSO). This role plays a key part in ensuring inspection readiness, regulatory compliance, and high‑quality delivery across clinical programmes.

Key Responsibilities

• Support the creation, revision, and implementation of GCSO quality and compliance policies, SOPs, and processes.
• Collaborate with Global Quality, Patient Safety, Regulatory Affairs, and external partners to ensure compliance with ICH GCP, GLP, PV and global/local regulations.
• Lead and drive inspection readiness activities across GCSO, serving as a central coordinator with inspection teams.
• Represent GCSO during internal and external audits/inspections, supporting preparation and follow‑up activities.
• Act as Regulatory Intelligence (RIN) Coordinator, reviewing regulations, identifying relevant SMEs, and ensuring CROs assess country‑specific regulatory impacts.

Skills & Experience Required

• 8+ years’ experience in the pharmaceutical industry, ideally within global Quality Assurance or Clinical Development.
• Strong expertise in GCP and GVP, with hands‑on experience in global audits and/or inspections.
• Minimum 2 years’ experience writing or revising SOPs.
• Demonstrated ability to interpret regulatory guidance and coordinate SME engagement across functions.
• Excellent communication and stakeholder‑management skills, with experience supporting audits, inspection readiness, and CAPA follow‑up.

To Apply:

• If you are interested and want to find out more about this role, please click to apply or contact Theo Charles to discuss further.

Extra information

Status

Open

Education Level

Secondary School

Location

Slough

Type of Contract

Full-time jobs

Published at

25-01-2026

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English