CNX Therapeutics | B Corp™ Certified
Manager, Quality GDP & Responsible Person
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Role Purpose
The Manager, Quality GDP & Responsible Person is responsible for leading the day-to-day operation, compliance and continuous improvement of Good Distribution Practice (GDP) activities across CNX Therapeutics.
The successful candidate will ensure compliance with Wholesale Distribution Authorisation (WDA) requirements and applicable GDP legislation, providing operational oversight and execution of supplier qualification, customer qualification, GDP batch release, returns, recalls and associated quality processes. Acting as a Responsible Person named on the Company's Wholesale Distribution Authorisations, you will support business continuity for GDP-regulated activities and contributes to the ongoing maintenance of inspection readiness across the GDP function.
You will work closely with internal stakeholders, external service providers and regulatory authorities, ensuring GDP activities are executed in accordance with regulatory requirements, company procedures and quality objectives, while supporting product supply, patient safety and organisational growth.
Key Accountabilities
- Act as a Responsible Person named on the Company's Wholesale Distribution Authorisations, ensuring compliance with applicable GDP legislation, licence obligations and regulatory requirements.
- Ensure wholesale distribution activities are conducted in accordance with applicable GDP requirements, company procedures and regulatory expectations.
- Lead the day-to-day operation and continuous improvement of GDP processes, ensuring activities are executed in accordance with company procedures, compliance targets and business requirements.
- Manage supplier qualification, customer qualification and Bona Fide activities, ensuring reviews, records and approvals are completed in accordance with regulatory requirements and established timelines.
- Perform GDP batch release activities, ensuring medicinal products are released in accordance with approved procedures, licence obligations and quality requirements.
- Lead transport qualification and GDP distribution assurance activities, including route risk assessments, transport validation review, temperature excursion assessment and ongoing monitoring of distribution networks, ensuring products are transported in accordance with GDP requirements and company procedures.
- Lead the management of returns, suspected falsified medicines, product recalls and recall simulations, ensuring activities are conducted effectively and in accordance with regulatory obligations and company procedures.
- Maintain Wholesale Distribution Authorisations and associated regulatory records, supporting licence variations, renewals and ongoing compliance activities.
- Conduct and support GDP investigations, deviation management, CAPAs and quality risk assessments associated with distribution activities, ensuring issues are appropriately documented, assessed and resolved.
- Lead GDP self-inspections and support regulatory inspections, customer audits and supplier audits, ensuring observations, commitments and corrective actions are effectively managed to completion.
- Monitor GDP compliance performance through defined KPIs, quality metrics and management reporting, identifying risks, trends and opportunities for continuous improvement.
- Support Quality Management Review activities through the provision of GDP performance data, compliance metrics and quality trend information.
- Provide GDP and Responsible Person support to product launches, acquisitions, integrations and other strategic business initiatives as required.
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Required Skills & Experience
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- Significant Quality Assurance experience within a GDP-regulated pharmaceutical, specialty pharma or biotech environment, ideally supporting commercial/marketed products.
- Eligibility and experience operating as a named Responsible Person (RP) on a UK WDA(H)
- Strong working knowledge of UK & EU GDP requirements and Guidelines relating to the wholesale distribution of medicinal products.
- Experience maintaining and providing oversight of a GDP-compliant Pharmaceutical Quality System, including deviations, CAPAs, change controls, complaints, recalls and quality risk management.
- Strong experience of pharmaceutical supply-chain quality, including storage, transportation and distribution of medicinal products.
- Experience qualifying, approving and maintaining oversight of suppliers, customers and third-party logistics providers (3PLs).
- Experience managing outsourced GDP activities, including Quality/Technical Agreements and ongoing performance and compliance monitoring.
- Experience conducting GDP audits, self-inspections and supplier/3PL audits, with responsibility for findings and remediation.
- Strong understanding of temperature-controlled distribution, temperature excursions, transport qualification and appropriate storage conditions.
- Experience managing product complaints, returns, suspected falsified medicines and product recalls from a GDP perspective.
- Strong knowledge of documentation, data integrity, record keeping and training requirements within a GDP-regulated environment.
- Ability to work closely with Supply Chain, Commercial, Regulatory Affairs and external logistics/distribution partners.
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