Process Quality Excellence Specialist
hace 2 días
Slough
About the Role This is a dual-focused clinical quality role combining Audit Hosting and Regulatory Intelligence (RIN) coordination within a global clinical sciences and operations environment. The role acts as a central point of contact between Quality Assurance, internal SMEs and external partners to ensure clinical quality systems remain inspection-ready and aligned with evolving GCP regulatory requirements. You will coordinate internal audits, support audit follow-up activities including CAPAs and manage regulatory intelligence updates impacting controlled documents across the organisation. About the Company You will be joining a global, science-driven biopharmaceutical organisation committed to advancing innovative medicines that make a meaningful difference to patients’ lives. With a strong focus on quality, compliance and collaboration, the company operates across international markets and partners closely with CROs and regulatory authorities to deliver high-quality clinical research in line with global standards. Key Responsibilities • Act as Audit Host for internal quality audits, serving as the primary coordinator between the auditing team and relevant internal SMEs, • Prepare for audits by coordinating document requests, scheduling meetings and ensuring stakeholder readiness, • Support SMEs during audits by facilitating responses to auditor queries, • Coordinate post-audit activities, including responses to findings, CAPAs and follow-up actions through to audit closure, • Act as Regulatory Intelligence (RIN) Coordinator for the Global Clinical Sciences and Operations group, • Monitor changes in GCP regulations, guidance and country-specific requirements impacting clinical operations, • Perform high-level gap assessments to determine impact on existing SOPs and controlled documents, • Identify and assign appropriate SMEs to review and update documentation based on regulatory changes, • Coordinate document updates, track timelines and actively chase stakeholders to ensure on-time completion, • 3–5 years’ experience within Clinical Quality in a pharma or CRO environment, • Strong GCP background with hands-on experience in GCP clinical trials, audits or inspections, • Experience supporting audits, including document provision and CAPA management, • Clear understanding of quality systems within clinical development (GCP only – GMP/GLP experience not suitable), • Experience with Regulatory Intelligence, regulatory surveillance or gap analysis is highly desirable, • Alternatively, experience in Regulatory Intelligence with some exposure to GCP audits will be considered, • Strong coordination, stakeholder management and follow-up skills, • Confident working with SMEs to interpret regulations and translate requirements into document updates, • Comfortable working in a hybrid environment and managing multiple priorities
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