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About the Role

This role is responsible for leading GMP compliance, supplier assurance, and product quality oversight activities for CNX Therapeutics. The position ensures products manufactured, tested, released, and distributed by third-party partners meet GMP requirements, Marketing Authorisation Holder obligations, and company quality standards. The successful candidate will collaborate with internal stakeholders, external service providers, and regulatory authorities to ensure GMP activities align with regulatory requirements, company procedures, and quality objectives, ultimately supporting product supply, patient safety, and organizational growth.

Responsibilities

Lead GMP compliance and Marketing Authorisation Holder (MAH) quality oversight activities across the CNX product portfolio.
Maintain quality oversight of contract manufacturing, testing, release, and packaging partners.
Lead the Supplier Assurance Programme for GMP and GDP service providers.
Establish, maintain, and review Quality Technical Agreements.
Lead Product Quality Reviews (PQRs) and oversee Stability Programmes.
Maintain oversight of GMP quality documentation, quality data, validation, and pharmacopoeial compliance activities.
Monitor GMP compliance performance through KPIs and quality metrics, driving continuous improvement.
Maintain inspection readiness and support regulatory inspections and customer audits.
Support regulatory inspections, customer audits, and Regulatory Affairs activities.
Provide Quality leadership for acquisitions, integrations, technical transfers, product launches, and due diligence.
Lead the management of GMP quality events, deviations, investigations, CAPAs, and change controls.
Maintain professional knowledge of emerging GMP, regulatory, and industry developments.
Promote a culture of quality and continuous improvement through stakeholder engagement, coaching, and training.
Live the CNX Values and support ESG principles.
Undertake other duties as delegated by the Quality Director or Senior Leadership Team.

Requirements

Bachelor’s degree in Life Sciences, Chemistry, Biochemistry, Pharmacy, or related discipline.
5+ years of Quality Assurance experience in a 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).

Work Type

Fixed Term Contract

Experience Level

5+ years

Education Level

Bachelor’s degree