Manager, Quality Assurance GMP (12 month Fixed Term Contract)

Role Purpose

The Manager, Quality Assurance GMP is responsible for leading GMP compliance, supplier assurance and product quality oversight activities across CNX Therapeutics.

The role ensures that products manufactured, tested, released and distributed through third-party partners are managed in accordance with applicable GMP requirements, Marketing Authorisation Holder obligations and company quality standards.

The successful candidate will work closely with internal stakeholders, external service providers and regulatory authorities, ensuring GMP activities are executed in accordance with regulatory requirements, company procedures and quality objectives, while supporting product supply, patient safety and organisational growth.

This role is a 12 month Fixed Term Contract opportunity.

Key Accountabilities

• Lead GMP compliance and Marketing Authorisation Holder (MAH) quality oversight activities across the CNX product portfolio, ensuring products are manufactured, tested, released and distributed in accordance with applicable regulatory requirements and company quality standards.
• Maintain quality oversight of contract manufacturing, testing, release and packaging partners, ensuring supplier performance, compliance obligations and product quality risks are effectively managed throughout the supply chain.
• Lead the Supplier Assurance Programme, ensuring appropriate qualification, audit and ongoing performance monitoring of GMP and GDP service providers.
• Establish, maintain and periodically review Quality Technical Agreements, ensuring appropriate quality and compliance responsibilities are defined across the supply chain.
• Lead Product Quality Reviews (PQRs) and oversight of Stability Programmes across the product portfolio, ensuring activities are completed in accordance with regulatory requirements and internal expectations.
• Maintain oversight of GMP quality documentation, quality data, validation and pharmacopoeial compliance activities, ensuring documentation supporting continued product compliance and lifecycle management is appropriately reviewed and approved.
• Monitor GMP compliance performance through defined KPIs, quality metrics and management reporting, driving continuous improvement initiatives where required.
• Maintain inspection readiness across GMP activities through effective supplier oversight, audit management and quality governance processes, and support the preparation and hosting of regulatory inspections and customer audits.
• Support regulatory inspections, customer audits and Regulatory Affairs activities through the provision and review of quality documentation and compliance information.
• Provide Quality leadership and support for acquisitions, integrations, technical transfers, product launches and other strategic business initiatives, including due diligence activities where required.
• Lead the management of GMP quality events, deviations, investigations, CAPAs and change controls impacting products and suppliers within scope.
• Maintain professional knowledge and competence through continuing professional development, monitoring emerging GMP, regulatory and industry developments to support compliance and continuous improvement.
• Promote a culture of quality and continuous improvement through stakeholder engagement, coaching, training and quality leadership.
• Live the CNX Values. Maintain high standards of ethics and support the company in its commitment to environmental, social and governance (ESG) principles.
• Undertake other duties and responsibilities as reasonably delegated from time to time by the Quality Director or Senior Leadership Team.

Required Skills & Experience

• Batchelor’s degree in Life Sciences, Chemistry, Biochemistry, Pharmacy, or related discipline
• 5+ years of Quality Assurance experience in biotech/pharmaceutical environment
• Demonstrated experience of commercial/GMP manufacturing environments and dosage forms
• Strong working knowledge of GMP Regulations and Guidelines
• Vendor/contract manufacturer (CMO/CDMO) oversight experience, including quality agreements, product quality review, stability oversight and supplier audits
• Experience managing deviations, investigations, root cause analysis, and CAPA
• Familiarity with validation processes and principles
• Experience with electronic Quality Management Systems (eQMS) systems (e.g., DotCompliance, TrackWise, MasterControl, Veeva etc)
• Internal and external audit experience (conducting and/or hosting)