Senior GMP Compliance Specialist (f/m/x) 100% // Johnson & Johnson in Zuchwil

Stefanie Aerni, Randstad jnj zuchwil
jetzt bewerben

job details

Zuchwil, Solothurn
Stefanie Aerni, Randstad jnj zuchwil
058 231 36 15


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 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

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). This includes the procedures and records required for the development, deployment and maintenance of quality system processes in order to assure the ongoing compliance with ISO13485, FDA QSRs and the Medical Devices Directive and other applicable regulations and standards.

  • Prepare and maintain regulatory inspection readiness plans for assigned sites
  • Execute internal audit as per approved schedule for other DePuy Synthes sites (worldwide scope, products and technologies)
  • Lead all assigned quality actions, and ensure all internal and external audit observations are investigated, have causes identified, action plans completed, and appropriate effectiveness monitoring
  • Ensure proper internal audit reporting, response review and approvals, communication of issues, and use of tracking and trending tools to monitor site compliance performance
  • Coach and develop users on Audit system as well as regulation requirements
  • Drive Compliance improvements, which result from internal audits, Quality Board Issues and other system indicators
  • Provide Front Room/ Back Room support during external audits
  • Guide Quality System Auditors and support staff as required to ensure appropriate control systems are in place and continually improved to meet changing regulatory, corporate and industry standards


Who we are looking for

  • University degree in Science, Engineering, Quality or other technical field
  • Work experience in a quality and/or compliance function is a major plus
  • Knowledge of Quality Systems (21 CFR 820/ISO 13485)
  • Very good communication in English

For this job we offer a mix between remote work and on-site work.

This role based in Zuchwil, Switzerland will initially be limited to approx. 12 months 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!