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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, identifying at-risk sites that require additional support or remediation.

• Ensure ongoing compliance with customer, regulatory and internal requirements.

• Manage and co-ordinate the Supplier Management Programme, including supplier audits, the preparation and review of Quality Technical Agreements, supplier qualification and vendor performance management for third-party suppliers.

• Prepare and maintain the third-party / clinical approved product and supplier lists.

• Prepare QP declarations for review and approval by the third-party QP at PCI.

• Prepare and review Product Quality Reviews (PQRs) in support of third-party QP release.

• Review and track third-party change controls with a product quality or regulatory impact.

• Support the management of the Manufacturing and Importation Licence held by the Millmount entity and the associated variations to it.

• Raise Deviations, Corrective Action Requests and Non-Conformance reports in a timely manner, ensuring issues are communicated to management.

• Generate SOPs, Forms, Job Aids and Work Instructions within the MasterControl system.

• Identify and support opportunities to improve processes and procedures.

• Undertake and manage specific or ad hoc projects as and when required to meet departmental and business needs, within the scope of the role.

Knowledge / Skills & Experience

Essential:

• Bachelor's degree in a scientific, technical or engineering discipline (or associate degree / diploma / certificate). Relevant experience may be considered in lieu of formal educational requirements.

• Minimum 5 years’ experience within the pharmaceutical and/or biological industry, including at least 2 years in a regulatory- or compliance-focused role.

• Strong working knowledge of EU regulatory requirements applicable to pharmaceuticals, with the ability to apply GMP regulations and international guidelines across all aspects of the role.

• Ability to set clear goals, communicate them effectively and ensure progress to completion against predefined targets.

• Demonstrated client-facing experience.

Desirable:

• Experience auditing external suppliers, contractors and vendors.

• Experience with regulatory filings and variations.

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.