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Quality Assurance (Compliance) Manager

Rivia

ZurichHybrid1mo ago
Employment
Full-time

About the role

  • Owning a function: You want to be the one who carries full accountability, not one voice among many in a large compliance team.
  • Working at the edge of biotech and software: The intersection of clinical data platforms, regulatory frameworks, and software validation is where you do your best work.
  • Being the trusted expert: You are the person clients and auditors talk to, and you know how to instill confidence in a regulated-industry audience.
  • Building with pragmatism: You understand the balance between a compliance programme built for Rivia’s fast-moving startup and getting ready to scale for a 500-person company. You leverage AI to streamline processes and automation. 
  • Organisation and detail: You balance pragmatism with an eye for detail and efficient organisation.
  • Compliance ownership: Take full accountability for Rivia's GCP compliance and required certification including ISO 27001, ISO 9001, and GAMP 5 programme. Maintain, evolve, and defend the certification posture as the product and organisation scale.
  • Audit management: Lead all external audits, surveillance reviews, and certification renewals end-to-end. No founder involvement required.
  • Client-facing compliance: Serve as sole point of contact for enterprise vendor questionnaires and client-initiated audits. Reduce deal friction and accelerate procurement cycles.
  • Documentation and records: Own and maintain all compliance documentation, including SOPs, risk registers, validation protocols, and CAPA records, ensuring they reflect and evolve to meet current product and process reality.
  • Cross-functional integration: Embed compliance checkpoints into engineering and product workflows. Translate regulatory requirements into practical tasks that teams can execute without losing pace.
  • Training: Design and deliver compliance training to keep staff audit-ready as the team grows.
  • Standards monitoring: Track evolving certification requirements and translate changes into practical implications for the platform and organisation.
  • 8+ years of hands-on experience in quality assurance within a digital, medtech, or pharma environment
  • Ownership and strong working knowledge of at least two of: ISO 27001, ISO 9001, GAMP 5 software validation 
  • Experience implementing and overseeing industry guidance (e.g. GxP, ICH E6 R3) and agency specific regulatory frameworks (e.g. FDA 21 CFR Part 11)
  • Direct experience managing external audits and client-initiated vendor qualification end-to-end
  • Implemented AI to monitor, document and improve processes more efficiently.

Our Values 

  • In it to Win it: Approach every challenge with determination, resilience, and a drive, aiming for the best outcomes and solutions.
  • Embrace change: We see change as an opportunity for growth, innovation, and improvement, continuously evolving to stay one step ahead
  • Why not?: Asking why not, instead of why, allows us to show our curiosity, allowing us to challenge assumptions and explore new possibilities.
  • Find the gap: We are curious and we proactively approach identifying opportunities and solving problems before they arise.
  • Collective accountability: We are one team, on one mission and we are committed to shared responsibilities and mutual support, enabling trust and collaboration.
  • Value-add solutions: Know better. Act better. We are dedicated to delivering meaningful and impactful results.

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