Are you an experienced Quality professional ready to lead compliance and quality systems in the pharmaceutical and medical device sector?
An international healthcare company based in Zug is looking for a
Senior Quality Assurance Manager & Responsible Person (Designate)
to oversee the local Quality Management System (QMS) and ensure full compliance with Swiss regulatory requirements.
This role offers the opportunity to shape and manage a robust QMS while serving as the key quality interface with authorities, partners, and global teams.
Your responsibilities
* Establish and maintain the local QMS in line with global GMP/GDP standards and Swiss law.
* Act as the main QA contact for local authorities, partners, and global functions.
* Manage key quality processes: deviations, CAPA, change control, complaints, and audits.
* Oversee supplier and customer qualification, and lead internal and external audits.
* Ensure readiness for inspections and support global QA during regulatory audits.
* Conduct and document product recalls/mock recalls as required.
* Prepare Quality Management Reviews and ensure compliance reporting.
* Serve as LMS administrator and local QA training lead.
* Support pharmacovigilance (PV) quality processes, documentation, and metrics.
Your profile
* Degree in Pharmacy or Life Sciences (Biology, Chemistry, or equivalent).
* At least 2–3 years of QA experience in pharma or medical devices.
* Solid knowledge of GDP; GMP and auditing experience preferred.
* Strong understanding of EU-GDP, HMG, AMBV, and Directive 2011/62/EU.
* Fluent in German and English (written and spoken).
* Organized, reliable, and detail-oriented with strong communication skills.
* Located within two hours of Zug and the associated logistics site.
What makes you stand out
* Experience as or eligibility to act as Responsible Person (FvP) in Switzerland.
* Proven track record with inspections and authority interactions.
* Experience implementing or managing eQMS and training systems.
* Practical, solution-driven approach and ability to work independently.
Why join?
In this key QA leadership role, you'll ensure the quality and compliance of products on the Swiss market while collaborating with global teams. You'll build and lead local quality processes, support regulatory interactions, and play a central role in strengthening the company's presence in Switzerland's healthcare environment.
Interested? Send an email to k.- or apply below