Quality Manufacturing Support Manager

Quality Manufacturing Support Manager role in a biopharmaceutical start-up operation based in Waterford City. This exciting opportunity is working for a company that markets a portfolio of medicines through its orphan, primary care and rheumatology business units. Head Quartered in Ireland, the company also has offices in the US and Europe.
The overall purpose of the role:
Reporting directly to the Quality Manufacturing Support Associate Director, the Quality Manufacturing Support Manager is
  • Responsible for ensuring the highest quality standards for the product portfolios by managing the operational quality system elements, ensuring all work is carried out in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulation and guidelines, safety and environmental guidelines.
  • This position is responsible for supporting the maintenance and management the Pharmaceutical Quality System and that it is consistently deployed and maintained for operations and supporting functions. The individual will initiate action to correct quality and or compliance concerns, inform as appropriate through the Quality Leadership Team. The individual will be responsible for supporting key quality tasks with respect to commercial products, development and clinical projects.
  • Ensure review of all Quality and production batch documentation is completed correctly, to achieve a high level of customer service and cGMP.
  • Ensure that Batch documentation, Laboratory results and related Quality System documentation is correct and approved prior to QA/QP release
  • Supports preparation of any Submission Documentation to support licence applications
  • Ensure SAP material changes are reviewed and correct prior to approval
  • Ensure customer / contract services Technical Agreements are implemented and maintained according to established procedures.
  • Continuously promote a positive safety culture. Implement Safety requirements as per site documentation including SOPs, Safety Statement
  • Provide support for the development, implementation and maintenance of the HTID Pharmaceutical Quality System and supplier management program.
  • Provide support for management of complaints, deviations, CAPA’s and change controls associated with commercial products.
  • Provide operation and maintenance support of quality documentation system.
  • Preparation of annual reports, annual product reviews and core documents.
  • Support supplier qualification and internal quality review.
  • Support Investigating out-of-trend/specification (OOT/S) reports.
  • Conducting internal audits and/or coordinating the HTID self-inspection program.
  • Supporting development projects
  • Work directly with other key Company departments to ensure compliance and productive working relationships.
  • Perform additional tasks as agreed to support effective running of the business.

Qualifications and Skills Required:

  • Bachelor’s degree in chemistry, biology or a related discipline is desirable.
  • 7 years’ experience working in Quality or Manufacturing, with a minimum of 3 years in a sterile manufacturing environment.
  • Experience with investigations, change controls and CAPAs.
  • Thorough understanding of quality systems and GMPs.
  • Good interpersonal skills and professional skills to interact at all levels.
  • Customer orientated with excellent communication and interpersonal skills to interact at all levels including senior executives, contractors, and colleagues’ skills and the ability to apply pragmatic logic to problem solving and issue resolution is also required.