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.