Senior Clinical Quality SOPs & QMS Lead (Hybrid)

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

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.