Boston Scientific QC Laboratory Manager M3 

Ireland, Cork 

731665362

• Location: Cork

• Contract Type: Permanent

• Reporting to: Associate Quality Director

• Closing Date: 24th October 2024

Purpose Statement

Management of the Operations Laboratories in Cork to provide a quality, efficient and cost effective testing service. The QC Laboratory Manager is responsible for ensuring that Chemical, Microbiological, Mechanical, Dimensional, Stability and any other testing executed in Operations Laboratories is conducted in accordance with cGMP. The QC Laboratory Manager is responsible for and shall provide support and guidance in the areas of cGMP, Compliance, Regulatory, Technical Investigations, Validation, test method optimization, technical transfers in the Cork Laboratory.

Key Responsibilities:

• Leadership of QC Analytical team to support timely execution of testing and release of Pharmaceutical and Medical Device products
• Support QC planning and scheduling activities as required.
• Maintains a full understanding and complies with all the regulations governing the quality system.
• Responsible for the maintenance and continuous improvement of the Quality System for the analytical laboratory compliant to FDA, GMP, ISO, and European directives.
• Delivery of key Quality and Performance Objectives.
• Site responsibility for the maintenance and continuous improvement of the Analytical Chemistry laboratory
• Supervision of the transfer of validated analytical methods into laboratory from donor laboratories.
• Ensures that non-conformances are investigated to determine root cause and that appropriate corrective actions are applied and in a timely manner.
• Selection, approval and on going monitoring of Contract laboratories.
• Provide technical guidance /trouble shooting in the event of equipment failure, out of specification results, method issues.
• Continuous improvement and systems development.
• Develops & manages the laboratory budget.
• Ensure that the implementation of the change control procedure are in conformance with the required standards.
• Contributes to site management operational and strategic initiatives.
• Ensures audit readiness, both internal and external
• Responsible for coaching, developing staff and completion of performance appraisal reviews.
• Ensure employees are trained to do their work and their training is documented.

Education & Responsibilities:

• Bachelor/Masters in Science or Science related discipline and have a minimum of 5 years’ experience in the Medical Device and/or Pharmaceutical Industry
• Demonstrated understanding and experience of the principles of GMP / GLP
• Demonstrated understanding of Analytical chemistry test methods and instrumentation
• Minimum of 3-year supervisory experience with the ability to motivate and develop departmental staff through effective feedback and coaching
• Proven success working well in a team environment, as well as proven leadership skills to manage a team of professionals through changing business needs.
• Experience & knowledge of regulation as well as experience of auditing by external regulatory authorities