Reporting to: Associate Quality Director
Closing Date: 24th October 2024
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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 providing support and guidance in the areas of cGMP, Compliance, Regulatory, Technical Investigations, Validation, test method optimization, and 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.Maintain a full understanding and comply with all regulations governing the quality system.Responsible for the maintenance and continuous improvement of the Quality System for the analytical laboratory compliant with 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 the laboratory from donor laboratories.Investigate non-conformances to determine root cause and ensure appropriate corrective actions are applied in a timely manner.Selection, approval, and ongoing monitoring of Contract laboratories.Provide technical guidance/troubleshooting in the event of equipment failure, out of specification results, or method issues.Continuous improvement and systems development.Develop and manage the laboratory budget.Ensure that the implementation of the change control procedure is in conformance with the required standards.Contribute to site management operational and strategic initiatives.Ensure audit readiness, both internal and external.Responsible for coaching, developing staff, and completing performance appraisal reviews.Ensure employees are trained to do their work and that their training is documented.Education & Responsibilities: Bachelor/Masters in Science or Science related discipline with 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 years 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.About us At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. We are solving some of the most important healthcare industry challenges. Together, we are one global team committed to making a difference in people's lives around the world.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran.
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