Our client is seeking a Head of Quality / Quality Manager to manage overall Quality responsibilities at their site. This role has 28 reports, including 2 QPs, QA Manager and QC Manager. This key role is part of the Site Leadership Team and reports to the Managing Director.
QP qualification is required (as this role will also be backup QP) together with 8+ years’ experience in Pharmaceutical Quality.
• As a Qualified Person you will have responsibility for product release. As such you will ensure that each batch released has been produced and tested in accordance with current EU GMP directives and the relevant marketing authorisation.
• Reporting to the Managing Director the Quality Manager is responsible for the management, direction and co-ordination of all quality activities across the site.
• As a key member of the site leadership team you will contribute to all areas of company strategy, policy development and general management.
• As Quality Manager you have responsibility for the following areas
• Quality Assurance
• Quality Control
• QP Function
• In your role you must remain independent of other departments within the company.
• You must ensure that adequate resources, equipment and facilities are available for Personnel within the Quality department to fulfil their responsibilities
• To ensure compliance with the requirements of Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP)
• To oversee and direct the management of the QA, QC, and the QP function.
• To ensure that adequate resources and appropriately trained and experienced personnel are available to manage the Quality System. This includes but is not limited to the following systems :
• Internal Auditing
• Process Deviation Reporting
• Customer Complaints
• Change Control
• Supplier and Subcontractor Approval, Complaints and Performance
• Batch File Review
• Material and Product Disposition Systems
• To manage the plant recall procedure.
• To oversee plant validation.
• To ensure adequate records are in place to provide full traceability.
• To ensure all GMP critical SOPs and batch records are approved by the Quality Department and to ensure that all Quality documentation is maintained up-to- date and compliant with cGMP.
• To lead all Regulatory and Customer GMP Inspections and to manage related follow-up activities.
• To manage the site internal auditing procedure.
• To approve and monitor contract manufacturers and contract testing laboratories.
• To be the contact person for interactions with the HPRA and other Regulatory Authorities as required.
• To act as Management Representative and to manage the maintenance of the Quality System as required by the Medical Device Regulations.
• Review customer complaints and modify processes as necessary to eliminate defects.
• Manage quality metrics across the site and ensure adherence to site quality targets.
• Drive key changes and continuous improvement in site Quality systems and procedures.
• To manage and guide the activities of the Quality Management personnel and to monitor and review performance.
• To perform the role of Responsible Person overseeing the wholesale activities of the organisation in compliance with WDA licence.
• A minimum of 8 years post-graduation experience in Quality environment with at least 3 years in a management role.
• A third level qualification in a scientific discipline and relevant experience in the pharmaceutical industry.
• In addition you must have fulfilled the education requirements for the role of the Qualified Person.
• Good organisational ability and initiative to be able to work to and meet deadlines in a result orientated environment.
• Strong leadership skills and the ability to work in cross-functional team environments, as well as independently.
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747