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Location:
Nijmegen, Provincie Gelderland, Netherlands
Job reference: R-026354
Posted date: May. 09, 2018

As a Quality Assurnace Manager you will ensure that Medimmune’s clinical supplies are manufactured in accordance with GMP, the product specification file and regulatory dossier taking responsibility for QP technical release of Medimmune’s products

Working as part of the R&D QA management team, you will lead the development and maintenance of the quality systems necessary to assure compliant delivery of clinical products to QA/MedImmune sponsored studies.

In addition you will provide advice on and contribute to the maintenance and development of appropriate GMP quality systems at Medimmune’s and contractors as well as manage Lot Disposition and QP certification activities across R&D QA sites.

Key Accountabilities

  • Provide advice to client groups in relation to quality assurance and GMP issues for Biologics Investigational Medicinal Product as required.
  • Perform internal audits of MedImmune’s GMP operations and facilities.
  • Act as SME in support of external audits of key suppliers
  • Manage the delivery of local GMP training (e.g. GMP induction, regulatory update training).
  • As part of the R&D QA team, manage the development and maintenance of GMP quality systems required to deliver Biologics IMPs to clinic.
  • Act as Site lead for nominated enterprise wide quality systems deployed at the Cambridge site.
  • Review and approve Medimmune’s site GMP documentation as required.
  • Review and approve Quality Agreements and other formal correspondence, e.g. Authorisation for further manufacture, Notes to file, as required.
  • Act as coordinator/EU QA SME in the event of a product recall.
  • Provide QA advice and support to client groups with regards to investigations and changes.
  • Support pack and label operations by providing support and advice to LCS group, review of labels, batch records and other necessary documentation as required.
  • Review batch records and data for products manufactured on behalf of Medimmune and perform lot status disposition.
  • Support Medimmune’s R&D QPs in certifying IMP batches for use in EU clinical trials.
  • Oversee the continual improvement and simplification of the Lot Disposition process.
  • Management of the lot disposition process and support of associated systems.
  • Review and comment on MedImmune’s clinical trial applications and responses to queries as required by function or CMC team roles.
  • Act as a CMC Team QA Lead, providing technical input to the team and facilitating communication between the team and functional QA groups.

Required Skills & Knowledge

  • BSc or equivalent, ideally in Pharmacy, Chemistry or a Biology based subject.
  • Considerable experience in a GMP QA role supporting IMP supply in the EU
  • Knowledge of the manufacture of Biotech products for clinical use in humans
  • In depth knowledge of GMPs as applied to IMP supply
  • Basic knowledge of GMPs as applied to Biotech products
  • Working knowledge of EU regulations governing supply of IMP.

Preferred Skills & Knowledge

  • Significant knowledge of Qualified Person function.
  • Use of electronic quality systems such as TrackWise and DMS systems
  • Well-developed knowledge of electronic quality systems
  • In depth knowledge of GMPs as applied to Biotech products.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the countries where the role is advertised.

Quality Assurance Manager - Biologics
MedImmune

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  • MedImmune, Nijmegen, Provincie Gelderland, NetherlandsRemove