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Head of Quality

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Date: Sep 16, 2021

Location: Larne Millbrook, GB

Company: Terumo BCT, Inc.

Location: Larne, Northern Ireland

 

 

Terumo BCT Ltd Larne manufactures a wide range of sterile solutions classified as Licensed Drug Products, Pharmaceutical ‘Specials’ and Medical Devices.

This role will lead the factory QA/QC Team, managing overall execution to quality processes in partnership with Manufacturing and Engineering.  It will also play an integral role in interpreting regulations and standards into Terumo BCT policies and procedures, and will own the ongoing maintenance, execution, and improvement of QMS areas of responsibility to maintain regulatory compliance.   Responsible for Product Quality support through all phases of production support and improvement. 

 

Duties will include:

  • Oversee and develop the Quality team, bringing individuals together with technical capability, enthusiasm, and influence to meet quality goals and drive improvement.
  • Ensure products are manufactured, tested, and released in compliance to EU GMP, through maintaining a robust and effective Quality Management System.
  • Lead site quality meetings to improve performance and product quality, using trends and process data.
  • Responsible as Legal Manufacturer, for specific products (as applicable).
  • Support manufacturing to produce products, improve product and process quality using quality management techniques, such as First Time Quality (FTQ) initiatives; identify and drive improvement projects to either gain efficiency, improve product quality, or cost down.  
  • Oversee and manage the throughput and backlog of inventory in incoming and final inspections, and staff/schedule accordingly.
  • Partner with Supply Chain function to monitor and manage quality across supply chain.
  • Monitor the health of QMS areas within areas of responsibility, and provide metrics to management as required, including any governing oversight boards. 
  • Positively influence the outcome of regulatory, notified body and customer audits through leadership of site preparation and communications.
  • Ensure that the Quality system is updated and maintained to the current GMP as required by European and American regulatory authorities, Eudralex Vol. 4, ISO 9001, ISO 13485 and MDSAP (as applicable.) 
  • Embrace the Terumo BCT core competencies of Respect, Integrity, Care, Quality and Creativity.

 

Applicants must possess:

  • At minimum, a Bachelor’s degree in a Life Science
  • Minimum of 5 years’ experience in a similar senior role within a Medical Device, Pharmaceutical Manufacturing, or relevant Regulatory field. 
  • Minimum 5 years’ experience leading a strong and effective QMS.
  • Strong Management skills.
  • Experience in leading audit responses to various Regulatory Authorities and notified bodies. 
  • Experience and knowledge of Eudralex Vol. 4, ICH Guidelines and Human Medicines Regulations 2012:1916 and EU Directive 2003/94/EC.
  • Knowledge of US and international medical device regulations and standards (CFR 820, MDD and ISO 13485).
  • The ability to work collaboratively across functions and cultures.
  • The ability to lead people and achieve results through others.

 

In addition, the following would be a distinct advantage:

  • Training/experience in FDA Quality System Regulation
  • Lead Auditor to EU GMP and ISO 13485:2016 standards.
  • Manufacture of Sterile drug products and working to Eudralex Vol 4 Annex 1.
  • Previously named on a MHRA (or equivalent) Manufacturer’s/Importer’s licence.

 

If you would like to apply for this role, please submit your CV before the closing date/time of 5.00 pm on Wednesday 5th May 2021.

 

 

 

Terumo BCT Ltd is an Equal Opportunities Employer and welcomes applications from all sections of the community regardless of their gender, marital or family status, religious belief or political opinion, disability, race or ethnic origin, nationality, sexual orientation or age.


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