Senior Clinical Quality Documentation Specialist

Planet Pharma; Slough; Hybrid; GBP 90,000 - 115,000; Full time

Job summary

Planet Pharma is seeking a Senior Clinical Quality Excellence Specialist for a hybrid role in Slough with a biotech client. The role focuses on SOP governance, lifecycle management, and QMS development to meet ICH-GCP standards.

You will collaborate with clinical operations and quality teams to ensure inspection readiness and continuous process improvement within a regulated environment.

Qualifications

• Extensive experience writing, revising, and managing SOPs in regulated pharma/biotech/CRO environments.
• SOP ownership and portfolio management experience.
• 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.

Responsibilities

• Author, review, harmonize, and maintain SOPs within the QMS.
• Manage full SOP lifecycle: governance, document control, change management, compliance.
• Develop SOPs for Clinical Operations, including study and site management, informed consent, and study docs.
• Support continuous improvement of the QMS and ensure alignment with regulatory requirements.
• Identify and mitigate quality and compliance risks across clinical studies.
• Partner with cross-functional stakeholders to drive process excellence and inspection readiness.

Skills

SOP governance

Document lifecycle

ICH-GCP knowledge

Quality management

Regulatory compliance

Tools

Veeva QualityDocs

Veeva QMS

iGrafx

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

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.