At a Glance
- Tasks: Create and manage SOPs to ensure top-notch quality in clinical operations.
- Company: Dynamic biotech firm focused on innovation and quality.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Inclusive workplace welcoming diverse talents and perspectives.
- Why this job: Join a team that drives excellence in clinical quality and compliance.
- Qualifications: Experience in SOP management and strong knowledge of GCP regulations.
The predicted salary is between 45000 - 55000 £ per year.
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 Quality Docs, Veeva QMS, and/or i Grafx
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.
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Senior Clinical Quality Documentation Specialist in Slough 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.
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We think this is how you could land Senior Clinical Quality Documentation Specialist in Slough
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We think you need these skills to ace Senior Clinical Quality Documentation Specialist in Slough
Some tips for your application 🫡
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✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Planet Pharma that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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