Our client, a multinational biotech company, now seek an experienced Head of QC Laboratories with responsibility for all Quality Control testing activities for this new hi-tech aseptic biotech manufacturing facility on site in Dublin.
As part of the leadership team, this hire will foster a quality ethos and culture for QC Laboratories, promoting regulatory compliance, right first time and continuous improvement within Quality Control. This hire with full responsibilities for QC Laboratories, for both QC testing and Microbiological testing in compliance with cGLP / cGMP, leading all aspects of the development of the QC team.
Responsibilities for Head of QC Laboratories, Biotech:
- Manage Key Performance Indicators within the Quality Control area to ensure adherence to local and global quality KPIs.
- Create and the management of QC annual budget for consumables, capital and headcount.
- Participate in global project teams relating to QC and wider quality activities.
- Manage Method Transfers/Validation, associated with Tech Transfers to and from the Biotech Manufacturing Facility Lead ensuring key milestones are achieved.
- Manage real-time review of QC data and trends associated with materials release and batch disposition associated with the Biotech product. (The management of these activities will take place on a shift rota and the future state may be asked to take place 24/7).
- Manage laboratory resources (instruments and personnel) to provide a service for testing of all QC and microbiological samples ensuring that personnel is trained all tasks within the laboratories and recruitment of experienced personnel.
- Management of testing schedules adherence to support the release of material to support manufacturing and disposition of the final product.
- Manage investigations related to QC following the site Deviation Management System, ensuring root cause analysis and assigning of CAPAs.
- Manage the Change Control process for QC, ensuring controlled implementation of changes.
- Ensure participation of the QC Biotech team in production and other site meetings.
- Participation in the preparation of, and represent the QC Department, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
- Manage Inspection readiness and close out of gaps identified for QC in the Inspection readiness assessment and Site Inspection Success Rating.
- Participation in the preparation of QC related documentation for regulatory submission and participation in regulatory affairs discussions associated with QC.
- Communication and liaison with other Biotech and company on Quality Control issues, providing guidance to others.
Requirements for Head of QC Laboratories, Biotech:
- Bachelors Degree in Science or other relevant field.
- 10+ years’ experience in the Pharmaceutical/Biopharma industry, of which 5+ years QC Laboratory Management experience
- Experience in Biotech product testing would be advantageous
- Extensive experience of both chemistry and microbiological testing
- Experience in budgetary control and audit preparation
- Thorough knowledge of GMP and current FDA & EMEA regulations
- Previous experience in managing the performance of personnel and that of the overall team
- Knowledge and experience of Lean Laboratories is preferable
- Excellent knowledge of GMP for aseptic pharma manufacture to FDA & EMA regulations.
- Experience managing and motivating a team.
- Project management skills.
- Knowledge in HPLC and Flow cytometry
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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