Senior Process Quality Excellence Specialist
hace 1 día
Slough
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.