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GMP Compliance Specialist // Johnson & Johnson.

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détails du poste

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détails du poste

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 120,000 people.

  • DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings, help advance the health and wellbeing of people around the world.

    Main Responsibilities

    As part of the Regulatory Compliance team of DePuySynthes, this role provides Quality System Compliance support to the assigned site(s) and ensure efficient Internal Audit process, site inspection readiness and overall compliance to ISO 13485, FDA QSRs and the Medical Devices Directive and other applicable regulations and standards.
  • Conduct Internal Audit as per Internal audit Schedule and ensure proper reporting & response review.
  • Train and Maintain users on the Internal Audit System.
  • Provide guidance and support to sites in routine readiness activities, self-assessments, improvements initiatives, and projects related to their Quality Systems.
  • Provide Guidance and support in observation response for 3rd party, Notify body or corporate inspection.
  • Assess compliance in Failure Investigation and Root Cause identification
  • Assess Action plan and Effectiveness Monitoring adequacy.
  • Provide assistance in Front Room/ Back Room during external audits
  • Act as Subject Matter Expert for any site External Inspection

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 120,000 people.

  • DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings, help advance the health and wellbeing of people around the world.

    Main Responsibilities

    As part of the Regulatory Compliance team of DePuySynthes, this role provides Quality System Compliance support to the assigned site(s) and ensure efficient Internal Audit process, site inspection readiness and overall compliance to ISO 13485, FDA QSRs and the Medical Devices Directive and other applicable regulations and standards.
  • Conduct Internal Audit as per Internal audit Schedule and ensure proper reporting & response review.
  • Train and Maintain users on the Internal Audit System.
  • Provide guidance and support to sites in routine readiness activities, self-assessments, improvements initiatives, and projects related to their Quality Systems.
  • Provide Guidance and support in observation response for 3rd party, Notify body or corporate inspection.
  • Assess compliance in Failure Investigation and Root Cause identification
  • Assess Action plan and Effectiveness Monitoring adequacy.
  • Provide assistance in Front Room/ Back Room during external audits
  • Act as Subject Matter Expert for any site External Inspection

  • qualifications

    Who we are looking for

    • University degree in Science, Engineering, Quality or other technical field
    • Equivalent degree and/or adequate associated work experience is acceptable
    • Work experience in a regulated industry
    • Work experience in a quality and/or compliance function is a major plus
    • Knowledge of Quality Systems (21 CFR 820/ISO 13485) within a regulated environment
    • Very good communication in English, German is advantageous
    • Work effectively with the other site compliance specialists and Site Business Partner

      This role based in Zuchwil, Switzerland will initially be limited to approx. October 2025 with the possibility to extend. If you are interested in working for a global leading health care company in a challenging role, then send us your application in English today. Or give us a call if you have any questions!

informations de contact.

nous sommes à ta disposition pour toute question.

FR

Fabio Romano

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