Senior External Quality Manager

Posted 07 August 2020
Job type Permanent
DisciplineLife Sciences & Engineering Technologies, Science Leaders & Specialists
ContactShane Browne

Job description

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.

The Position:

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.

The Person:

  • 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.