Technical Responsible Person (FvP) / Senior Quality Assurance Specialist (m/f/d)

For our Quality Department in Switzerland, we are seeking a:

Technical Responsible Person (FvP) / Senior QA – full time (100%), temporary assignment (8 months), in Zug.

To strengthen our team during a parental leave, we are looking for an experienced Technical Responsible Person (FvP) / QA in Switzerland. In this key role, you will be responsible for the implementation and maintenance of our Quality Management System (QMS), ensuring compliance with regulatory requirements, and performing batch market release activities for the Swistzerland. You will work closely with various internal and external stakeholders and ensure that all activities comply with Swiss legislation as well as European GDP and GMP requirements.

Key Responsibilities

• Ensure quality assurance and compliance within the Pharma, Surgical, and Vision Care business units and act as the Technical Responsible Person (FvP) for importation and wholesale distribution activities in accordance with AMBV requirements for Bausch & Lomb Swiss AG.
• Perform batch release of medicinal products and medical devices for the Swiss market.
• Ensure compliance with quality requirements through the management of non-conformances, CAPAs, and complaints.
• Maintain the Quality Management System (QMS) and conduct internal audits and training management activities.
• Communicate with Swiss health authorities, manage regulatory activities in Switzerland, and maintain product registrations/licenses.
• Support pharmacovigilance and materiovigilance activities for the Swiss market, by handling routine activities (including literature research, reporting obligations, managing adverse event reports and participation in product recalls). Regularly report and monitor Quality Performance Indicators (QPIs).
• Qualify suppliers, service providers, and customers.
• Organize and conduct audits to ensure quality and compliance.
• Act as the responsible person for advertising.

Your Profile

• University degree in Life Sciences, Pharmacy, Chemistry, or an equivalent scientific discipline.
• Qualified to work as FvP as per Swiss requirements. (I-SMI.TI.17).
• Several years of experience in the pharmaceutical industry as (deputy-)FvP, preferably in a senior position within compliance or quality; project management experience is advantageous.
• Strong knowledge of GMP, GDP, MDR requirements, and pharmaceutical regulatory standards.
• Excellent problem-solving and decision-making skills with a strong analytical mindset.
• Sound business and technical knowledge. Work experience with sterile medicinal products is advantageous.
• Excellent interpersonal and communication skills for effective interaction with internal and external stakeholders.
• Accurate and conscientious working style, with high personal integrity and accountability.
• Ability to efficiently manage and continuously improve complex processes.
• Very good German language skills (minimum C1 level). and fluent English.

We offer: