QC Laboratory Manager M3

1 month ago

Cork, Ireland Boston Scientific Full time

  • Location: Cork 

  • Contract Type: Permanent

  • Reporting to: Associate Quality Director

  • Closing Date: 24th October 2024

  

At Boston Scientific, we draw the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints are welcomed and encouraged. If you require accommodation during the recruitment process please do not hesitate to contact a member of the Talent Acquisition team for a confidential discussion. 

  

  

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance 

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. 

  

 

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

 

 

About us 

 

 

Purpose and Passion – Comprehensive Benefits – Life-Work Integration – Career Growth 

 

 

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people lives around the world. This is a place where you can find a career with meaningful purpose – improving lives through your life’s work. 

 

 

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen. 

 

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran 

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