Our client, a global leader in innovative components for the Biotech and Pharmaceutical industries, has retained us to recruit a QUALITY MANAGER.

Leading the Quality function on site and contributing as a member of the leadership team this person will;

  • Drive a compliant work environment, leading a high performing team to deliver against defined business goals, objectives and key performance indicators.
  • Maintain the Sites Quality Management System in line with the relevant Standards and Regulations.
  • Ensure compliance to the Corporate quality management systems, policies, procedures and protocols.
  • Enhance customer relationships by improving quality performance across key indicators.
  • Drive and embed a preventive action culture via root cause investigation, risk assessments in collaboration with Operation’s.
  • Provide leadership for the site in regard to customer and / or product requirements.

Additional responsibilities include:

  • Host the site Quality Management Review in line with agreed frequency, ensure action follow-up and timely close out.
  • Ensure sufficient quality support and competencies are in place to support /network projects to ensure flawless transition into Operations e.g. tech transfer.
  • Responsibility for the approval of change controls, qualification of new equipment and/or validation of new processes.
  • Identify and drive quality improvement projects.
  • Responsible for the quality data trending e.g. CAPA, OOS, Deviations, Customer Complaints and Change Requests and driving quality improvements across the site.
  • Interface with customers to ensure concerns/complaints are communicated and effective corrective and preventive actions are implemented in a timely manner.
  • Defines audit plans for QA process and internal audits for the plant.
  • Ensure capability of hosting of third party audits, ensuring general audit readiness throughout the business.
  • Audits suppliers and supports issues of delivery specifications for raw materials and auxiliary materials in co-operation with Quality Systems.
  • Final Batch release decision, including responsibility for the execution and final disposition of IPC and incoming testing as well as trending of this data.
  • Responsibility for the data gathering and reporting of Annual Product Reviews, as required.
  • Prepares monthly QA statistics.
  • Establishes the duties and responsibilities of reporting staff, regularly assessing performance and acting as a coach and mentor.
  • Interface with other sites with respect to sharing of best practices and harmonisation / standardisation of procedures and practices.

We require candidates with a relevant degree coupled with several years’ experience in a Quality leadership role, in a regulated manufacturing environment.  Experience should include Quality Operations and Quality Systems management.

This is an excellent and exciting opportunity to participate in and contribute to the continuing growth of a successful multinational company, with good career development prospects.  Please send full career details, quoting position no. G23020 to David Garvey at info@gmb.ie .  For an initial confidential discussion, please telephone David on +353 (01) 2867692. 

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