Quality Excellence Specialist

Planet Pharma; Greater London; On-site; GBP 65,000 - 90,000; Full time

Job summary

Planet Pharma is seeking a Senior Process Quality Excellence Specialist to join its Clinical Quality team on a long-term contract. The role requires a strong background in GCP, ICH guidelines and Quality Management Systems across global clinical programmes.

Key responsibilities include SOP development and governance, maintaining the QMS, and driving continuous improvement in clinical processes with cross-functional teams.

Qualifications

• Significant experience in Clinical Quality, Clinical Operations Quality, QA or QMS.
• Hands-on experience writing, revising and managing SOPs in regulated clinical environments.
• Excellent knowledge of GCP, ICH guidelines and clinical trial processes.
• Experience maintaining Quality Management Systems (QMS).
• Ability to translate regulatory requirements into practical, compliant procedures.
• Strong stakeholder engagement across global cross-functional teams.
• Experience driving continuous improvement and process optimization.

Responsibilities

• Lead development, review and continuous improvement of SOPs, policies and procedural documents across Clinical Operations.
• Support ongoing maintenance and enhancement of the QMS.
• Ensure clinical processes align with GCP, ICH guidelines and regulatory requirements.
• Partner with Clinical Operations, Quality and cross-functional teams to identify process improvements.
• Provide quality guidance and support to stakeholders across global clinical programmes.
• Support process mapping, procedural governance and quality-related change activities.
• Monitor industry trends and regulatory developments to keep procedures current.

Skills

GCP & ICH guidelines

Quality Assurance

SOP development

Stakeholder engagement

Process mapping

Regulatory interpretation

Tools

Veeva QMS

iGrafx

Job description

Senior Process Quality Excellence Specialist

A global biopharmaceutical organisation is seeking an experienced Senior Process Quality Excellence Specialist to join its Clinical Quality team on a long-term contract basis.

This is an excellent opportunity for a quality professional with a strong GCP, Clinical Operations and Quality Management Systems (QMS) background who enjoys driving quality improvements, governance and procedural excellence across global clinical programmes.

What You'll Be Doing

• Leading the development, review and continuous improvement of SOPs, policies and procedural documents across Clinical Operations.
• Supporting the ongoing maintenance and enhancement of the Quality Management System (QMS).
• Ensuring clinical processes align with GCP, ICH guidelines and regulatory requirements.
• Partnering with Clinical Operations, Quality and cross-functional teams to identify process improvements and strengthen compliance.
• Providing quality guidance and support to stakeholders across global clinical programmes.
• Supporting process mapping, procedural governance and quality-related change activities.
• Monitoring industry trends and regulatory developments to ensure procedures remain current and compliant.

What We're Looking For

• Significant experience within Clinical Quality, Clinical Operations Quality, Quality Assurance or Quality Management.
• Strong hands-on experience writing, revising and managing SOPs within a regulated clinical environment.
• Excellent working knowledge of GCP, ICH guidelines and clinical trial processes.
• Experience supporting and maintaining Quality Management Systems (QMS).
• Proven ability to interpret regulatory requirements and translate them into practical, compliant procedures.
• Strong stakeholder engagement skills with the ability to work across global, cross-functional teams.
• Experience driving continuous improvement and process optimisation initiatives.

Nice to Have

• Experience with Veeva QMS.
• Experience with process mapping tools such as iGrafx.
• Pharmaceutical or biotechnology industry experience within a global organisation.