Quality Systems Manager

2021-10-28 15:59:202049-03-13Team Horizon
Job TypePermanent
Start Date
AdvertiserAshling Guthrie
Job Ref#2230
Job Views144
Experienced in Quality Systems? Looking to take the next step up in your career? Look no further! Team Horizon have an opportunity for a Quality Systems Manager to join an advanced Biologics Manufacturing site with an exciting future ahead. If you are ambitious and driven to make a real impact on a global scale, read on to find out more and apply.
Why you should apply:
  • You’re passionate about your profession and strive for excellence in everything you do.
  • You’re ambitious and thrive in working environments where high standards and patient safety are key.
  • You bring new ideas to the table, are well versed in industry best practice and innovative talent solutions, and you will be integral to the continuous growth of the organization.
What you will be doing:
  • Lead and develop the Quality System function and team to deliver a best in practice Quality System driving performance and compliance.
  • Take responsibility for compliance with Quality System including, Management Review Coordinator, Management Representative and NTM coordinator, Supplier Program, CAPA, Change Control, Training, Product Quality Review, Inspection Readiness & Management, Internal Audit, Complaints, Quality & Technical Agreements, as well as Continuous Improvement and Simplification Initiatives.
  • Prepare and maintain Site Master File, Quality Manual and Quality Plans.
  • Ensure that products manufactured meet the requirements of end-users, Regulatory Authorities and the company.
  • Develop and maintain performance measurements of the quality system and report on this at management review meetings and during quality performance meetings.
  • Liaise with Quality and Compliance Group, FDA, HPRA and other Regulatory bodies to ensure Quality Systems compliance by all departments and personnel.
  • Manage ongoing Quality Systems Compliance issues, and present technical data to stakeholders to ensure prompt decisions on related issues.
  • Act as Designee for Biologics QA Site Lead as required.
What you need to apply:
  • You will have a 3rd Level Qualification in Science, Quality or Engineering to Degree Level (Masters Preferable) with 8 + Years’ experience in the healthcare/pharmaceutical/biopharmaceutical industry
  • Minimum of 3 Years People Management experience
  • Demonstrated audit/inspection management experience
  • In-depth knowledge of GMP Requirements and Regulations.
  • Ability to make Quality decisions and run the business while keeping patient-focused and safeguarding the company’s reputation.
  • High level of attention to detail and mental concentration to ensure accuracy and total compliance with procedures.
  • Results-driven striving to meet all targets and metric standards as set by department/site and division leader.
  • Strong communication skills, both verbal and written, are required for the execution of this role.
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