Roche
Head of Compliance and Quality Governance(m/w/x)
Vollzeitnur vor OrtSenior
Kaiseraugst
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
Supporting pharma with digital endpoint data collection and mobile app development for neuroscience R&D. Seven years of MedTech/Digital health experience with GxP, ISO 13485, and ISO 27001 required. Overseeing CSV, V&V, and infrastructure qualification.
Anforderungen
- Master’s degree in life sciences, engineering, or related fields
- At least seven years of experience in quality management, information and regulatory affairs in MedTech/Digital health, with a strong focus on software
- Knowledge and experience with Pharma GxP, ISO 9001, and medical device framework (ISO 13485)
- Knowledge and experience with governance of ISMS under ISO 27001
- ISO 27001 Lead Auditor / Implementer
- CISMA / CISA CRISC
- Knowledge and experience with governance of AI and ML regulatory oversight (US and EU)
- Experience with DHT and cloud solutions
- Previous experience with governance of data privacy requirements, or willingness to learn
- ICH E 6(R3) GCP certification and previous exposure to clinical projects and audits under ICH-GCP
- Excellent team player with a “can-do” attitude, comfortable in a multicultural environment and under pressure
- Hands-on mentality
Aufgaben
- Support pharmaceutical companies with digital endpoint data collection
- Enable development of digital endpoints and associated mobile applications
- Ensure compliance and success in medical device clinical investigations
- Support development teams in defining SDLC process for compliance
- Oversee CSV, V&V, and infrastructure qualification
- Collaborate on implementation and periodic review of processes
- Oversee disaster and business/trial continuation strategies
- Collaborate on cybersecurity and information security strategies
- Support operation teams in QMS process implementation
- Ensure product and process documentation meets regulatory requirements
- Manage risk oversight for business, clinical, product, and security
- Collaborate on risk management implementation and maintenance
- Coordinate and represent the company during external audits
- Coordinate internal audits and maintain supplier controls
- Oversee legal, security, privacy, and regulatory compliance
- Assume role of Management Representative as per ISO 13485
- Oversee and lead training management
- Oversee regulatory strategies for DHT and digital endpoints
- Align with clinical, market, and sales strategies
- Manage communication with regulatory authorities and notified bodies
- Assist Clinical Operations in managing clinical trials
- Align sales strategies with regulatory standards and clinical evidence
- Maintain up-to-date knowledge of relevant regulations
- Assume PRRC role for Indivi as legal manufacturer
- Oversee international data privacy requirements
- Collaborate on legal questions related to contracting and quality agreements
- Collaborate on legal requirements for data collection
- Maintain knowledge of legal requirements impacting the product
- Lead and guide a small team with direct reports and contractors
- Define and implement best practices and tools
- Facilitate open communication and decision-making
- Promote a culture of open discussions and timely decisions
- Conduct performance reviews and provide constructive feedback
- Identify training and development opportunities
- Update key stakeholders on project statuses and strategic initiatives
- Anticipate risks and develop mitigation strategies
Berufserfahrung
- 7 - 10 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Digital Health Technology (DHT)
- Pharma GxP
- ISO 9001
- ISO 13485
- ISO 27001
- CISMA
- CISA
- CRISC
- AI
- ML
- DHT
- ICH E 6(R3) GCP
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Indivi erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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Supporting pharma with digital endpoint data collection and mobile app development for neuroscience R&D. Seven years of MedTech/Digital health experience with GxP, ISO 13485, and ISO 27001 required. Overseeing CSV, V&V, and infrastructure qualification.
Anforderungen
- Master’s degree in life sciences, engineering, or related fields
- At least seven years of experience in quality management, information and regulatory affairs in MedTech/Digital health, with a strong focus on software
- Knowledge and experience with Pharma GxP, ISO 9001, and medical device framework (ISO 13485)
- Knowledge and experience with governance of ISMS under ISO 27001
- ISO 27001 Lead Auditor / Implementer
- CISMA / CISA CRISC
- Knowledge and experience with governance of AI and ML regulatory oversight (US and EU)
- Experience with DHT and cloud solutions
- Previous experience with governance of data privacy requirements, or willingness to learn
- ICH E 6(R3) GCP certification and previous exposure to clinical projects and audits under ICH-GCP
- Excellent team player with a “can-do” attitude, comfortable in a multicultural environment and under pressure
- Hands-on mentality
Aufgaben
- Support pharmaceutical companies with digital endpoint data collection
- Enable development of digital endpoints and associated mobile applications
- Ensure compliance and success in medical device clinical investigations
- Support development teams in defining SDLC process for compliance
- Oversee CSV, V&V, and infrastructure qualification
- Collaborate on implementation and periodic review of processes
- Oversee disaster and business/trial continuation strategies
- Collaborate on cybersecurity and information security strategies
- Support operation teams in QMS process implementation
- Ensure product and process documentation meets regulatory requirements
- Manage risk oversight for business, clinical, product, and security
- Collaborate on risk management implementation and maintenance
- Coordinate and represent the company during external audits
- Coordinate internal audits and maintain supplier controls
- Oversee legal, security, privacy, and regulatory compliance
- Assume role of Management Representative as per ISO 13485
- Oversee and lead training management
- Oversee regulatory strategies for DHT and digital endpoints
- Align with clinical, market, and sales strategies
- Manage communication with regulatory authorities and notified bodies
- Assist Clinical Operations in managing clinical trials
- Align sales strategies with regulatory standards and clinical evidence
- Maintain up-to-date knowledge of relevant regulations
- Assume PRRC role for Indivi as legal manufacturer
- Oversee international data privacy requirements
- Collaborate on legal questions related to contracting and quality agreements
- Collaborate on legal requirements for data collection
- Maintain knowledge of legal requirements impacting the product
- Lead and guide a small team with direct reports and contractors
- Define and implement best practices and tools
- Facilitate open communication and decision-making
- Promote a culture of open discussions and timely decisions
- Conduct performance reviews and provide constructive feedback
- Identify training and development opportunities
- Update key stakeholders on project statuses and strategic initiatives
- Anticipate risks and develop mitigation strategies
Berufserfahrung
- 7 - 10 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- Digital Health Technology (DHT)
- Pharma GxP
- ISO 9001
- ISO 13485
- ISO 27001
- CISMA
- CISA
- CRISC
- AI
- ML
- DHT
- ICH E 6(R3) GCP
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Indivi erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Indivi
Branche
Science
Beschreibung
Indivi is a TechBio company enabling precision and personalised medicine in neuroscience R&D.
Noch nicht perfekt?
- Roche
Head of Compliance and Quality Governance(m/w/x)
Vollzeitnur vor OrtSeniorKaiseraugst - Abbott
Ethics and Compliance Director, EPD(m/w/x)
Vollzeitnur vor OrtSeniorAllschwil, Basel - Roche
Head of QA for QC(m/w/x)
Vollzeitnur vor OrtSeniorKaiseraugst - Idorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Vollzeitnur vor OrtSeniorBasel - ten23 health
Head of IT(m/w/x)
Vollzeitnur vor OrtSeniorBasel, Visp