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
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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