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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.
Job Responsibility:
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
Requirements:
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