Quality Assurance Regulatory Compliance Specialist
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.
Summary of Role
The QA Regulatory Compliance Specialist is responsible for the establishment and ongoing management of third-party and clinical supply chains within PCI’s clinical regulatory compliance function. The role supports right-first-time QP release and works closely with clients and internal stakeholders in the management and oversight of regulatory change across multi-site supply chains.
Main Purpose of Job
The role is responsible for the supply chain establishment and compliance oversight of third-party and clinical products within PCI’s clinical regulatory compliance department, ensuring quality and regulatory requirements are met throughout the product lifecycle.
Main Responsibilities
- Responsible for the creation and maintenance of the Product Specification File (PSF) for the clinical supply chain where QP certification is performed.
- Develop and manage the Quality Systems and Compliance frameworks that support the maintenance and release of clinical supply chains at PCI.
- Maintain the Approved CMO list for the clinical supply chain.
- Maintain the Supply Chain / CMO Risk Register, id...
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