Quality Assurance and Regulatory Affairs Manager in Genetics
ExperisLausanne- Permanent
Introduction
Client : Provider of medical laboratory diagnostics for prescribers and hospitals in Switzerland.
Your Tasks
Promote and embody the company vision and policies while maintaining the genetic laboratory's licensure and accreditations. Manage and enhance the Quality Management System (QMS) in compliance with ISO 15189, ISO 17025, IVDR, and company standards, assisting with quality-related issues and fostering a culture of quality through education.
Communicate significant changes affecting laboratory capabilities to accreditation bodies, and prepare accreditation dossiers while accompanying auditors and coordinating responses to findings. Identify and document non-conformances, assess risks, and conduct root cause analyses, reporting trends at quality meetings.
Oversee post-market incident activities, drive continuous improvement through monitoring indicators and corrective actions, and organize annual Quality Management Review meetings with relevant teams. Ensure compliance of in-house devices with IVDR requirements, collaborate with procurement on supplier compliance, and implement risk management procedures.
Represent the Quality and Regulatory functions during M&A due diligence and integration processes, and participate in crisis management to ensure business continuity while performing other assigned duties as needed.
Your Profile
Education and Experience
- Bachelor's degree or master's degree in a technical / process engineering / QA discipline, with significant related professional experience within the laboratory environment.
- Prior in-depth experience working in an ISO 15189 accredited diagnostic laboratory with a focus on Quality Management Systems.
- Ideally experience with medical device regulation and / or in-vitro diagnostic directive regulation.
- 3 years of People Leadership Operations experience, preferred.
- Fluent in French and English, German is a plus
- Minimum Years Recommended and / or Preferred : 8-10 years
Required skills
We Offer