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.
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Quality Excellence Specialist 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.
