Global Head of Quality Systems

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

**Job Overview**

The Global Head of Quality Systems position holds the overall responsibility for compliance to all applicable regulations pertaining to all operations functioning on the assigned site (Zug/Switzerland) as well as corporate compliance to all applicable regulations including GMP pertaining to all the markets currently being served 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. Ensures the organization's quality system comply with all relevant standards, regulations, licenses and certifications.

**Main**Responsibilities**
- Strongly supports 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/her area of responsibility.
- Provides effective leadership, training, and mentorship to the Quality organization for his/her area of responsibility.
- Provides a system that supports the further career development of employees and ensures that the company can attract and retain the brightest employees.
- Inspires cross-functional and cross-regional networking and knowledge exchange.
- Ability to create an environment that promotes great performance, inspirational leadership and positive morale.
- Sets Quality objectives and ensures that targets are achieved for his/her area of responsibility.
- 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.
- 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.
- The incumbent may be required to undertake duties not specified in the job description commensurate with the role as required by business need.

**Minimum**requirements**
- Minimum of 10 years’ experience in Regulatory Affairs, Clinical Affairs or Quality Assurance within the medical device industry.
- Extensive experience in GMP and other Regulatory compliance requirements.
- Strong leadership skills.
- Proven expertise in the design and implementation of quality processes in a world-class medical device manufacturing organization.
- Self-confidence and the ability to work with all levels of the organization.
- High level of ethics and integrity.
- Ability to understand and adapt to different cultures and market needs.
- Fluent in written and spoken English.

**Preferred Qualifications**

- Bachelor’s or master’s degree in a relevant scientific or technical field, or equivalent work experience in the medical device industry.
- High seniority to ensure collaboration with Managing Director and other senior staff on eye level.
- German & Mandarin language skills are advantageous.

**We Offer**
- Challenging assignments in a fast-growing and innovative industry.
- A multicultural team and modern working environment with state-of-the-art facilities and technologies.
- A place where we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange