Director Global Quality

vor 1 Woche

Zug, Zug, Schweiz SHL Medical AG Vollzeit

Job Overview


The position of the Director global Quality of SHL Medical AG holds overall responsibility for compliance to all applicable regulations pertaining to all operations functioning on the assigned site as well as corporate compliance to all applicable regulations including cGMP pertaining to all the markets currently being served by the operations functioning on the assigned site.

It is the lead quality assurance function for the respective quality system/site of responsibility.

Actively provides guidance to multiple departments and site regarding compliance to all applicable SHL Corporate Quality and Regulatory procedures, including applicable Agency policies and regulations.

Job holder is directly involved in the establishment of corporate procedures.

Follow up on quality activities to ensure the organization's quality system comply with all relevant standards, regulations, licenses and certifications.


Main Responsibilities

  • Strongly support CQRO to implement the Quality strategy and the decisions taken by the CEO and BOD.
  • Responsible for the company's Quality Compliance for corporate and his site.
  • Responsible for establishing, standardizing where applicable and maintaining a global quality management system according to national and international standards and legislation for his area of responsibility.
  • Sets Quality objectives and ensure that targets are achieved for his area of responsibility.
  • Is responsible for evaluating the results of all quality assurance activities and for preparing recommendations for the CQRO about significant changes that need to be made to the organization's processes, systems, technology, inputs, or vendors for his area of responsibility.
  • Responsible for alignment and maturity of customer Quality Assurance Agreements
  • Responsible for continuous process improvement of global infrastructure Computer System Validation including reviewing and approving validation activities as appropriate.
  • Global process owner of selected processes such as Document Control, Change Control, Management Review as assigned.
  • Responsible for maintaining and improving enterprise process management. Provide effective leadership support, training, and mentorship to the Quality organization for his area of responsibility.
  • Shared leadership responsibilities:
  • Strives for continuous improvements within area of responsibility to reach high quality standards and always look for innovation to meet current and future customer requirements. Responsible for standardizing and aligning the activities and processes of SHL sites.
  • Inspire cross functional and cross regional networking and knowledge exchange.
  • Provides a system that supports the further career development of employees and ensures that the company can attract and retain the brightest employees.
  • Creates an environment that promotes great performance, inspirational leadership and positive morale.
  • The incumbent may be required to undertake duties not specified in the job description commensurate with the role as required by business need. SHL Medical AG | Job Description
  • The incumbent is required to comply with all internal and external rules and standards. For decisions that are not covered by such rules and standards, the incumbent acts to the best of his/her knowledge in consideration of the interests of all stakeholders.
  • The incumbent will ensure that the same principles are observed in his/her area of influence.
  • The incumbent's exemplary behavior characterizes the cooperation within SHL and with all stakeholders involved.
  • The incumbent signs correspondence and tasks according to his / her function and SHL's signature regulations.
  • The incumbent has the discretionary power towards SHL employees associated with his / her function and SHL signature regulations.

Minimum requirements

  • Minimum of 10 years' experience in Regulatory Affairs, Clinical Affairs or Quality Assurance.
  • Proven expertise in the design and implementation of quality processes in a worldclass medical device manufacturing organization.
  • Selfconfidence and the ability to work with all levels of the organization.
  • Operates in a way that never compromises ethics and integrity.
  • Fluent in written and spoken English.

Preferred qualifications

  • Operates in a way that never compromises ethics and integrity.
  • Strong leadership skills.
  • Ability to understand and adapt to different cultures and market needs.
  • Extensive experience in GMP and other Regulatory compliance requirements.
  • German and/or Mandarin are a plus

We Offer

  • Modern working environment with stateoftheart facilities and technologies
  • Challenging assignments in a fast growing and innovative industry
  • Position in a dynamic, international team of highly skilled professionals
  • Flexible working hours and a remote work policy
  • Numerous opportunities for personal and professional development within a global organization
  • Centrally located

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