Quality Assurance Director

Role Description

My client is a Global Pharmaceuticals company and a publicly traded, clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye. In conjunction with the CPL Group they are looking to set up a new start-up manufacturing facility and are looking to recruit for a Quality Assurance Director for its new facility based in Athlone.

 

 ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Responsible for developing the strategic vision for the Quality organization and supporting the execution of the site goals. Key member of the Site Leadership Team.
  • Responsible for ensuring that commercial (and where relevant investigational) release of products is conducted in accordance with applicable legal requirements (i.e. QP release etc), including batch record review, analytical testing, and investigation / resolution of deviations and associated investigations.
  • Responsible for the Quality Control organization, including internal/external microbiology, chemistry and stability testing.
  • Manage the interface between the Ireland site and the corporate Quality organization and ensure that the objectives of the site quality organization are aligned and delivered in accordance with corporate objectives and quality plans.
  • Responsible for the selection, functional design, growth and development of the Quality organization staff at all levels.
  • Ensures that all suppliers are appropriately qualified and for the maintenance of Quality oversight of suppliers and vendors supporting product manufacturing and testing, including audits, quality agreements, etc.
  • Generation and review of site related information and data for regulatory submissions and approval of submissions related to the site.
  • Responsibility to ensure that site is validated in accordance with global requirements and for maintenance of the validated state of all required systems, equipment, and processes on an ongoing basis through oversight of the site validations function.
  • Responsible for compliance of the Ireland manufacturing site - understand current and new regulations and guidelines and ensure that appropriate processes and procedures are implemented.

 

MINIMUM EDUCATION & PREVIOUS EXPERIENCE REQUIRED:

Education Required: BS in chemical or biological science or chemical engineering. Postgraduate degree preferred.

Experience Required:

  • At least 8 year’s experience working in a sterile pharmaceutical manufacturing organization with at least 5 years of senior management experience (Manager or Senior Manager of a key site function) and at least 5 year’s experience in a quality function. Ophthalmic manufacturing experience a plus.
  • Industry related knowledge: US and European regulatory requirements, design and validation of sterile manufacturing equipment and systems. Demonstrated experience and ability to act as a QP with extensive knowledge of QP regulations and obligations and how these are applied across the quality management system.
  • Thorough understanding of global Quality systems and operational best practices. Experience in leading interaction’s with regulatory agencies and demonstrated results in leading successful regulatory authority inspections. Experience in lean manufacturing concepts and/or six sigma and their application within the quality system a considerable advantage.

 

Suitable applicants should email their cv to aileen.cahill@cpl.ie or call me on 01-6146007 for a confidential conversation today. 

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