This innovative global biotech organisation is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. A biotechnology pioneer since 1980, this business has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Due to continued expansion and strategic transitioning of resources into Ireland with responsibility for the organisation's contract manufactured product, a new position has arisen in the organisation for a Senior Manager - External Quality to join the organisations External Quality Group.
In this role, you will be an integral quality member of the organisation's cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain etc. In addition you will:
- Serve as the main Quality point of contact for deviations, change controls, CAPAs author and revision of quality agreements and batch disposition etc. related to the organisation's products.
- Manage CMOs to contractual obligations relative to Quality Agreement, specifications, quality, safety and regulatory requirements.
- Review completed production batch records as necessary and approve master batch records and other cGMP documents from CMOs / Contract Laboratories.
- Provide quality oversight of the manufacturing, testing, and release of the organisation's products at CMOs.
- When necessary, facilitate communication regarding deviations, change controls, complaints and batch disposition between the CMO and staff members.
- Meet with Quality, Production, Regulatory, and Logistics personnel at the CMO sites as necessary or during regularly scheduled meetings for issues relating to the organisation's products.
- Represent quality and quality activities from the CMO site on the organisation's project teams.
- Provide Quality support of CMO site activities (e.g., NPI, tech transfer, PPQ, filings, etc.) site in accordance with the Quality Agreement.
- Ensure that the CMO Site has an appropriate Data Integrity program and if needed conduct DI assessment at that site.
- Representation at product-specific Regulatory Inspections and/or during Notified Body audits of CMO Site, as presenter as applicable or required.
- 10 + years' biotech or pharmaceutical industry experience with a steer towards Quality Management.
- QP eligibility desirable.
- Quality background either at site or external management of CMO's is desirable.
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.