Senior Quality Assurance Specialist

I'm working with a biotechnology organisation developing next-generation therapies for patients with serious diseases. They are looking for a Senior Quality Assurance Associate to join their Quality team and play a key role in ensuring GMP compliance, supporting product release activities, and driving continuous improvement across quality systems and manufacturing operations. The Role You will provide Quality Assurance oversight across manufacturing and support functions, ensuring regulatory compliance and product quality standards are maintained at all times. You will also contribute to the development of quality systems, support inspections and audits, and act as a key quality partner to operational teams. This position would suit an experienced QA professional who thrives in a fast-paced sterile GMP environment and enjoys balancing compliance, stakeholder engagement, and continuous improvement initiatives. Key Responsibilities:

• Provide QA support and oversight across manufacturing and operational functions.
• Review batch documentation and support GMP product release activities.
• Manage deviations, CAPAs, change controls, investigations, risk assessments, and OOS events.
• Author and review SOPs, policies, and GMP documentation.
• Support internal audits, regulatory inspections, and client audits.
• Deliver GMP compliance training and drive continuous improvement initiatives.
• Act as a key quality partner to cross-functional teams and deputise for QA leadership when required. Requirements:
• 5+ years' experience in Quality Assurance within a sterile GMP manufacturing environment.
• Strong knowledge of GMP, Quality Management Systems, deviations, CAPAs, and change control.
• Experience with eQMS platforms, regulatory inspections, and customer audits.
• Excellent communication, stakeholder management, and problem-solving skills.
• Proactive mindset with a passion for quality, compliance, and continuous improvement. For more information, get in touch - jamie.keith@cpl.com