QC Lab Manager - Cell Therapy - Dublin West - Dublin


Location: Ireland

Negotiable

Job Type: Perm

Industry: Biotech-Pharma-Medical-Device-Jobs

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 karen@jobcontax.com for review or call 353 1 7978720 to discuss in confidence.


QC Lab Manager - Cell Therapy - Dublin West - Dublin


Employer

​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


Job Description

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.


Requirements

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


Package

Excellent benefits package

Performance Related Bonus

Health Insurance

Pension

Flexibility 

Paid Maternity/Paternity Leave

Educational Assistance Programme

Zero Absence Award

Talent & Development Programme

Occupational Health & Wellness Programme


Contact

Karen McHugh is the consultant managing this position.

If you have any queries about this role, you can contact him by e-mail karen@jobcontax.com or phone +353-1-7978720


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