Quality Manager (Pharma Sector)

PCO Manufacturing, are looking for a driven Quality Manager to join their Quality Department.

This role will be reporting directly to the Head of Quality & Regulatory Affairs.

PCO Manufacturing is the market leader in the Parallel Importer sector in Ireland holding 600+ authorisations from both the HPRA and the EMA. At their repackaging facility in Co. Meath, with over 140 employees, they are passionate and driven to maintain that excellence and leadership in our sector. Due to their ongoing development and expansion, they now have an opportunity for an experienced Quality Manager to join their team. If you are looking for an exciting new role in which you can truly have a significant input and influence, please get in touch.

About the Role

The company is driven by their high quality ethos across everything they do. As Quality Manager, you will drive this across all areas in the company, ensuring their practices, processes, and their people are trained, skilled and operating to the highest quality standard demanded in their sector.

Responsibilities

  • Management and motivation of the QA & QC Teams and the day to day activities of the department. 
  • Develop, monitor and report on the agreed KPIs and Quality Metrics for the organisation, in a timely and insightful manner. 
  • Ensure all areas in the business understand their responsibilities, their performance and expectations from a quality perspective. 
  • Report on a regular basis to the Head of Quality & Regulatory Affairs, and on a weekly basis to the wider Management Group.
  • Report monthly as part of the Quality Management Review and Departmental Review Meetings.
  • Ensure the maintenance and continuous improvement of the Quality Management System (QMS) in the organisation in accordance with EU GMP and EU GDP on behalf of, and in conjunction with, the QP and RP(s).
  • Drive initial & continuous training programmes for all teams, and ensure records and standards are maintained, in a timely and accurate manner. 
  • Drive the management of Change Control System and the management of Deviation System, and CAPA System
  • Planning and reporting of internal audits and assigning suitable personnel to these audit exercises, taking place throughout the company. 
  • Implementation and utilisation of Quality Risk Management principles (QRM) across all GMP/GDP activities on site and will be expected to represent the Quality function during all compliance audits.
  • The participation and management of the reviews of process performance, product quality and of the quality management system. 
  • An advocate for continual improvement and will encourage best GMP/GDP practice across the site through ongoing staff engagement and Quality initiatives.
  • Drive and encourage continuous improvement and development of the Quality team members in order to deliver excellence. Ensuring you have strong people management initiatives in place that drives effective individual performance management and individual development opportunities in your team.

About You

  • A degree in a science discipline is preferred.
  • Previous experience of working in the Pharma sector is critical for this position, and ideally you will be an accomplished people manager, with 3-5 years working as a Quality Manager.
  • Previous experience as an RP or eligibility to become an RP or a QP would be an excellent advantage.
  • Excellent interpersonal and communication skills. Have a desire and ability to drive and improve a fast-paced department while maintaining excellent standards and being cognisant of business needs.
  • Personally driven by all aspects of Quality and be innovative and inspirational in how to drive Quality across the organisation, engaging the ears and minds of our teams to put Quality first in all aspects of their work.
  • Experienced in Quality systems and processes and will add value by introducing or developing smart technologies and processes that improve efficiencies and produce insights on all quality matters and metrics in the organisation.
  • A strong team player, motivated by what can be achieved through people and so will be experienced in engaging and motivating all stakeholders in the organisation.

Please apply with your CV and a brief cover note telling us why this position interested you to careers@pco.ie Thank you.