Senior Clinical Quality Documentation Specialist
Company: Planet Pharma Agency
- Location: Slough, United Kingdom
- Work mode: Hybrid
- Seniority: Senior
- Employment type: Contract
- Posted: 2 days ago
- Offer language: English
Job description
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
ABOUT PLANET PHARMA
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
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.
www.planet-pharma.com
