Job Type: Perm
Job ID: JO-1908-19286
Consultant: Karen McHugh
Are you a QC Lab Manager with 10 years’ experience in the Biopharma industry and 5+ years lab management experience?
If you have the relevant experience, please forward your CV to firstname.lastname@example.org for review or call 353 1 7978720 to discuss in confidence.
QC Lab Manager - Cell Therapy - Dublin West - Dublin
JobContax is a preferred supplier to one of the world's leading BioPharma companies.
With major capital investment happening in their Irish plants, this is an exciting time to join the team
Responsible for the overall management of separate Quality Control laboratories supporting the manufacture of Cell Therapy.
The QC laboratories operate on 24/7 and other shift rotas as required.
Ensure that QC laboratories are set up and operate in compliance with current Good Laboratory Practice / Good Manufacturing Practice at all times.
Develop and maintain excellent communication and collaboration between QC and other work areas.
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.
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.
Manage an effective QC documentation system.
The QC Manager will prepare, review and approve documents as required.
Ensure QC operation readiness for HA inspections (PAI, directed, other)
Ensure the QC department is in an audit ready at all times 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.
Ensure that the laboratory is kept clean, tidy and safe at all times.
Generate, implement and control of QC annual budget for consumables, capital and headcount.
As required, act as designee for the Quality Head, Cell Therapy in their absence.
Participate as required in global project teams relating to QC and wider quality activities.
Participate fully in any cross functional training initiatives.
Actively foster, in cooperation with other staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
Ensure timely completion of all SOP, reading, training and assessment.
Degree in Science or other relevant field.
More than 10 years’ experience in the Pharmaceutical/Biopharma industry and minimum of 5 years QC Laboratory Management experience
Experience in Cell Therapy 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 individual team members and that of the overall team
Knowledge and experience of Lean Laboratories is preferable
Previous experience in setting up a new QC laboratory is desirable
Excellent organisational, communication, interpersonal and report writing skills
Strong analytical knowledge, particularly in HPLC and Flow cytometry
Demonstrable experience managing, motivating and leading a team
Ability to adapt to changing priorities
Excellent benefits package
Performance Related Bonus
Paid Maternity/Paternity Leave
Educational Assistance Programme
Zero Absence Award
Talent & Development Programme
Occupational Health & Wellness Programme
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail email@example.com or phone +353-1-7978720
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