Position: Senior Clinical Quality Excellence Specialist Location: Hybrid - Slough Client: Biotech Type: Full-time contract Main Responsibilities Author, review, harmonize, and maintain SOPs and procedural documents within the Quality Management System (QMS). Manage the full SOP lifecycle, including governance, document control, change management, and compliance activities. Develop SOPs covering Clinical Operations processes, including study management, site management, informed consent, and study documentation. Support continuous improvement of the QMS and ensure alignment with GCP and regulatory requirements. Identify and mitigate quality and compliance risks across clinical study operations. Partner with cross-functional stakeholders to drive process excellence and inspection readiness. Main Requirements Extensive experience writing, revising, and managing SOPs within a regulated pharma, biotech, or CRO environment. SOP ownership Proven experience managing large SOP portfolios and document lifecycle activities. Strong knowledge of ICH-GCP, GCP regulations, and clinical trial operations. Background in Clinical Operations, Clinical Quality, or Quality Management. Experience with QMS development, maintenance, and continuous improvement. Expertise in SOP governance, document control, procedural compliance, and change management. Nice to Have: Experience with Veeva QualityDocs, Veeva QMS, and/or iGrafx We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
Senior Clinical Quality Documentation Specialist employer: Planet Pharma
Join a leading biopharmaceutical organisation in Slough, where innovation meets collaboration. As a Scientist in Antibody Formulation Development, you'll thrive in a dynamic work culture that prioritises employee growth and offers unique opportunities to contribute to groundbreaking research. With a focus on professional development and a supportive team environment, this role promises a rewarding experience for those passionate about advancing biopharma solutions.
