QA Operations Team Lead
This role will lead a team of QA Drug Substance Specialists providing oversight to Drug Substance manufacturing operations. This is a critical role within the Quality organisation with responsibility for supporting the manufacturing operations team, ensuring compliance with cGMP and corporate and local SOPs.
- Lead a team of QA Drug Substance Associates providing QA oversight to technology transfer and commercial manufacturing
- Supervise direct reports on a day to day basis, provide training and communications, assignment and prioritisation of work of direct reports.
- Manage performance, delivery of objectives and career development of direct reports
- Provide QA review and approval of SOPs, risk assessments, change controls and other documentation, as applicable, associated with Drug Substance manufacturing operations
- Ensure that Drug Substance manufacturing operations are conducted according to appropriate cGMP behaviours and compliance to SOPs, batch manufacturing records and other cGMP documentation, as applicable.
- Liaise with Manufacturing Operations to ensure that all deviations, investigations and batch manufacturing records review comments are adequately addressed and closed out in a timely manner as defined in SOPs.
- Work with Manufacturing Operations to ensure that all CAPAs, change controls, self-inspection observations, etc. relating to manufacturing operations are addressed and closed out in the required time frame.
- Coordinate with internal Quality peers to ensure on-time disposition of drug substance material.
- Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions.
- Lead and/or represent QA on multidisciplinary teams, as required.
- You should have a degree in Science or Engineering with experience working in the pharmaceutical or Biopharmaceutical industry
- Knowledge of trouble shooting and problem solving skills; e.g. formal root cause analysis such as Ishikawa diagrams, FMEA etc. as well as an ability to coach and mentor teams through complex problems.
- Strong experience in the biotechnology and/or pharmaceutical industry within a Quality role, preferably in Operations support or similar.
- Experience in supporting Technology Transfer projects would be an advantage.
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