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Quality Systems & Compliance Manager

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Dublin
  • Sector: Other
  • Date posted: 07/02/2019
  • Job reference: BBBH94042

Associate Director of Quality Management Systems (Global)

My client, a global CDMO is currently seeking an Associate Director of Global Quality Management Systems to join their team. In this position you will be supporting both the domestic and international sites though the cohesive implementation of quality systems.

In this role you will have responsibility for the QMS support and compliance oversite of activities. A key aspect of this role will be in providing inspection readiness including providing risk mitigating actions. The ideal candidate would understand working across different cultures and would be comfortable making high level decisions. This is an individual contributor position with no direct reports however within the role there is the potential scope to grow and develop a team.

There will be travel involved with this position.

  • Identify continuous improvement opportunities within the quality management system focused on the elimination of non-value-added activities and improved system efficiency's.
  • Develop and compile network Quality metrics and KPIs underpinning the global quality strategy and company objectives with regular reporting to Senior Leadership.
  • Can establish effective working relationships with people, across different organisations, manufacturing sites and cultures.
  • Provide above site quality and compliance review and approval of components of the quality management systems including change control, deviations, customer audits and CAPA's, with associated trending to identify and mitigate against future risk.
  • Provide oversight for the execution of manufacturing site internal audit programs and participate where required in on site regulatory and/or significant customer inspections
  • Keep track of new and emerging regulatory expectations and ensure that these requirements are incorporated into the quality system on an ongoing basis.

Qualifications and Experience

  • Degree in Life Sciences. In addition, whilst a Qualified Person status is not required for this position QP training and/or licensed QP experience would be an advantage.
  • Minimum 10 years' experience in Pharma API or drug product QA and/or QC oversight in FDA regulated environments.
  • Experience gained working as part of a CMO organisation and/or significant experience in providing quality and compliance oversight for CMOs.
  • Demonstrated knowledge of Quality Management System tools and continuous improvement methodologies.
  • Understands and maintains strong working knowledge of GxP, global regulations and guidelines for pharmaceutical companies.

For more information on this and other potential opportunities in this area please contact Kathryn Whyte on 016455250