Quality Site Head
We are currently partnering with a forward‑thinking life‑science organisation committed to advancing high‑quality therapeutics and medical technologies. This leadership position, based in Switzerland, plays a pivotal role in shaping quality operations and compliance frameworks at a regulated manufacturing site.
You will be responsible for:
* Providing strategic oversight of the site's Quality Assurance function, acting as a key member of the extended leadership team and collaborating closely with cross‑functional stakeholders across and beyond the site.
* Ensuring the facility maintains full adherence to all relevant quality, regulatory, and compliance standards, while driving continuous improvement in processes, systems, and operational efficiency.
* Designing and delivering core Quality System training, including GMP onboarding, annual refresher courses, Good Documentation Practices, and deviation management/writing training.
* Leading the preparation and execution of external assessments, serving as the primary host for customer audits, compliance inspections, and qualification visits.
An ideal candidate should have the following qualifications:
* A Bachelor's degree in a relevant scientific or engineering discipline (e.g., microbiology, cell biology, molecular biology, biochemistry, chemical engineering, or quality management).
* At least 10 years of experience within pharmaceutical or medical device environments, with a strong background in Quality Assurance, Quality Engineering, or GMP‑regulated quality functions.
* A minimum of 3 years in a supervisory or management role, ideally overseeing quality teams.
* Deep understanding of quality management systems and regulatory frameworks applicable to medical device and pharma manufacturing, including ISO 13485, ISO 9001, ISO 14971, EU MDR 2017/745, and FDA 21 CFR Parts 820, 210, and 211.
* Strong analytical and problem‑solving abilities, including expertise in root‑cause analysis.
* Excellent organisational, communication, presentation, facilitation, and technical writing capabilities.
* Full professional proficiency in French and English.
If this opportunity interests you, please apply!
NOTE: Only shortlisted candidates will be contacted. Candidates must have the right to work in Switzerland (e.g., EU citizens or valid Swiss work permit).
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