Quality Assurance and Regulatory Affairs Manager in Genetics
80-100%

Unilabs è il più grande fornitore in Svizzera di servizi diagnostici di laboratorio per medici e ospedali e impiega circa 800 persone.

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.

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

Excellent interpersonal, organizational & communication skills with excellent attention to detail.
Self-motivated and driven critical thinker able to work in high pace and rapidly changing environment.
Responsive problem solver and action oriented.
Ability to affect change.
Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions.

Un ambiente di lavoro stimolnte e dinamico con una dimensione internazionale
L'opportunità di assumersi delle responsabilità e sviluppare il proprio potenziale
Un'atmosfera di lavoro positiva in un ambiente che favorisce la collaborazione e una cultura aziendale che promuove il rispetto e il riconoscimento
Interessanti prestazioni sociali, settimana lavorativa di 40 ore e 5 settimane di ferie all'anno
Un forfait annuale per le proprie analisi personali e tariffe speciali per le procedure di radiologia eseguite all'interno del Gruppo Unilabs

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Sig. Antonio Gambin,