Associé Qualité (Contrat)

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Rolle

Vor Ort

CHF 90.000 - 110.000

Vollzeit

Vor 13 Tagen

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Benefits dieser Stelle

Helsana health insurance
Meal vouchers CHF 90 at partner cafe
25 days vacation
Voluntary benefits: fitness and bank

Zusammenfassung

SOPHiA GENETICS is seeking a Quality Associate to join its Quality Team in Rolle. The role focuses on NC, CAPA, and CCP management, supporting an international organization with patient-centered mission.

You will work in a hybrid setup, with involvement across departments to ensure audit readiness and compliant quality processes. The position runs as a contract until 31 May 2027, starting ASAP.

Qualifikationen

  • Working knowledge of CAPA, NC, CCP and other quality documentation processes.
  • Direct experience within a Quality Control / Quality Assurance function essential, ideally within a similar scientific, medical or pharmaceutical environment.
  • Experience with ISO 9001 and ISO 13485 standards.

Aufgaben

  • Manage NCs and CAPA end-to-end, including root cause analysis and verification.
  • Support CCP activities, ensuring changes are assessed, documented, and approved.
  • Collaborate with Supply Chain, Procurement, Data Science, and IT to gather evidence and close actions on time.

Kenntnisse

CAPA
NC
CCP
Quality documentation
English Fluent

Tools

JIRA
Veeva

Jobbeschreibung

Description

Do you have experience in Quality Assurances with NCs and CAPA? Are you available for a contract opportunity imminently? If this sounds like you and you are driven by purpose, join the SOPHiA GENETICS Quality Team as a Quality Associate, and enable us to make a positive impact on the outcomes for cancer and rare disease patients worldwide.

This is a contract opportunity until 31/05/2027. This is a hybrid role, and you can expect to be in our office in Rolle at least 3 days per week.

Our Mission

We believe there is a smarter, more data-driven way to make decisions in healthcare and our cloud-native AI powered SOPHiA DDM Platform makes that vision a reality on a daily basis. You will have direct input to our mission to democratize data-driven medicine for the ultimate benefit of cancer and rare disease patients across the globe.

Your Mission

As part of our Quality team, this role supports the team during periods of absence and an increased workload, taking ownership of Non-Conformity (NC) management, Corrective and Preventive Actions (CAPA), and the Change Control Process (CCP).

The value you bring
  • Conduct ongoing reviews of open and historical NCs to close gaps and ensure we're audit-ready ahead of our next inspection
  • Manage CAPAs end-to-end — from root cause analysis through implementation and effectiveness verification
  • Support Change Control Process (CCP) activities, ensuring changes are properly assessed, documented, and approved before implementation
  • Partner with cross-functional teams — Supply Chain, Procurement, Data Science, and IT — to gather evidence, document conformity, and close out actions on time
  • Identify emerging non-conformities proactively, assessing risk and recommending appropriate remediation
  • Maintain accurate, audit-ready records in Veeva and Jira throughout quality processes
Requirements

To be best set for success, we see you bringing:

  • Working knowledge of CAPA, NC, CCP and other quality documentation processes
  • Direct experience within a Quality Control / Quality Assurance function essential, ideally within a similar scientific, medical or pharmaceutical environment
  • Experience with ISO 9001 and ISO 13485 standards
  • Systems experience with ticketing and document management tools essential, ideally Veeva & JIRA
  • You'll bring a commercially focused and business enabling mindset, providing guidance on conformity rather than policing against rule
  • As an international organization, English is our primary business language, and you will need to be fluent (both written and spoken) to be suitable
  • You will be joining an organisation with the patient at the heart of every decision and action, driven by purpose as we pursue exponential growth.
Benefits

You will be joining an organisation with the patient at the heart of every decision and action, driven by purpose as we pursue exponential growth.

Business recognition and accolades include:

  • World's most innovative companies (Top 10)
  • World's smartest companies (Top 50)
  • 100 Best Places to Work in Boston
  • Top 10 European Tech Startup
  • Top 10 European biotechs startup to watch
  • Top 25 East-Coast Biotech to watch

Our benefits package is comprehensive, but varies internationally in-line with local standards and laws. You can discuss a full breakdown with us, but as a brief overview:

  • Sickness and Accident coverage through Helsana
  • Meal Vouchers at 90CHF PM with our partner cafeteria
  • 25 days vacation
  • Voluntary benefits including Fitness and Bank Partnerships
  • A fun and engaging work environment, with Rest & Entertainment space, full stocked free coffee machine and free fruit.
  • Free parking in an easy to access location
Our DNA

Like the strands of DNA itself, SOPHiA GENETICS and the team are deeply interconnected and reliant on each other to deliver. There are common threads across the team. Things that bind us together. Those things are Relentless Curious; Resilient & Nimble and Fearlessly Adventurous

Our Virtues

At SOPHiA GENETICS we established our 7 Virtues to clarify how our principles show up each day through action. We decide; We do; We Collaborate; We Innovate; We Empower; We Adapt and We Learn.

At the centre of our Virtues is our Mantra, We Care, which provides a constant reminder of the compassionate, benevolent, and hopeful nature of our mission and how it should be threaded through each of our Virtues and everything we do. Learn more about our DNA and Virtues on our Careers portal

Starting Date: ASAP

Location: Rolle, CH

Contract: Temporary Contract until 31/05/2027

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