Senior Process Quality Excellence Specialist

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.

• Support the creation, revision, and implementation of GCSO quality and compliance policies, SOPs, and processes.
• Collaborate with Global Quality, Patient, 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.

• 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.

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

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