The QC Manager is responsible for managing QC Testing and Microbiological Testing activities for a Cell Therapy manufacturing facility.
What does this job involve?
- The QC Manager will be responsible for the overall management of separate Quality Control laboratories supporting the manufacture of Cell Therapy.
- Ensure that QC laboratories are always set up and operate in compliance with current Good Laboratory Practice / Good Manufacturing Practice.
- The QC Manager will implement and maintain standards of GLP and analytical practice consistent with current regulatory expectations.
- Supervise QC Executives including training, recruitment, motivation, discipline and performance appraisal.
- Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all QC and microbiological samples.
- The QC Manager will lead the QC work stream of tech transfer and start-up of Cell Therapy products assuring the milestones of the project are reached.
- Manage the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence. Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per SOP.
- Ensure the QC department is always in an audit ready condition for both internal and external audits (HPRA, FDA, corporate, customer).
- Actively lead and support major projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.
- Implement and maintain standards of safety to ensure a safe working laboratory.
- Generate, implement and control of QC annual budget for consumables, capital and headcount.
- Participate as required in global project teams relating to QC and wider quality activities.
The next QC Manager should have a degree in Science/Engineering with at least 8 years’ experience in the Pharma or Biopharma industry. You should also have 4 years’ experience in a management position. Cell Therapy testing would be advantageous but not required.
If you’re interested in working with a start-up facility for one of the worlds largest Pharma companies then send your CV now. Excellent packages on offer with great work life balance.
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