Quality Manager

Job Title: Quality Manager
Contract Type: Contract
Location: Dublin
REF: 124240
Contact Email: laurentina@rftgroup.ie
Job Published: over 1 year ago

Job Description

Quality Manager
Our client’s quality group operates a fully integrated quality management system to support internal GxP activities and oversight of external service providers.
This role is a one-year contract role. Our client operates a flexible hybrid (remote and office) based work environment.

  • Review and release of clinical trial materials and GLP materials used in development programs.
  • Review and approval of quality control documentation (specifications, methods, etc), as may be required.
  • Review and Quality authorisation of protocols related to nonclinical development programs.
  • QA SME and team member in cross functional teams supporting clinical, CMC, and non-clinical development programs.
  • Oversight and qualification of CDMOs and GxP service providers
  • Lead and manage assigned Quality specific projects such as nitrosamines and vendor management systems.
  • Management and maintenance of quality systems such as training and change management.
  • Contribute and lead continuous improvement quality initiatives.
  • QA auditing/oversight support for ongoing non-clinical development programs
  • Support the development of new QA related GXP systems.
  • Process validation protocol review/authorisation, support for process validation and Transport Validation activities.
  • Quality support for commercialisation preparation activities which may include vendor audits, labelling review, Review/authorisation of CMC related documentation, PAI/inspection readiness, etc

Knowledge and skill requirements:
  • Minimum of 8 years' experience working within a QA (GMP/GxP) function in the healthcare, pharmaceutical sector, with a minimum of three years in a managerial role
  • Pharmaceutical development experience (phases I-III) working with small molecule programs preferred. Demonstrated experience in playing a leading role / managing project.
  • Ability to work in autonomous and team environments with flexibility.
  • Demonstrated initiative and decision-making skills.
  • Ability to communicate effectively with management and fellow peers.
  • Experience in preparation of final validation and product launch activity preferred.
  • Experience with FDA audit PAI requirements including preparation and on-site readiness; GCP related inspection experience a plus.
  • Comfortable in working and managing operations in a virtual biotech environment with extensive external partner environment.
  • QP experience a plus

Educational requirements
B.SC or equivalent
Additional postgraduate qualifications a plus

For further information on this QA Manager position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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