QA Regulatory Compliance Specialist

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. We are looking for a QA Regulatory Compliance Specialist (FT maternity cover). Main purpose of job: The role is to implement and execute tasks relating to the introduction and maintenance of third party/clinical products within the clinical regulatory compliance department in PCI. Main responsibilities: Creation and maintenance of Products Specification File (PSF) for Clinical supply chain where QP certification is performed. Developing and managing Quality Systems & Compliance to support the maintenance and release of clinical supply chains at PCI. Maintenance of Approved CMO list for Clinical Supply Chain Maintenance of Supply Chain/CMO Risk Register, highlight at risk sites that need additional support or remediation. Ensure on-going compliance with customer, regulatory and internal requirements. Management and co-ordinate Supplier Management Programme, including supplier a...