Roche
Head of Compliance and Quality Governance(m/w/x)
Full-timeOn-siteSenior
Kaiseraugst
New Job?Nejo!
Your personal AI career 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.
Requirements
- 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
Tasks
- 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
Work Experience
- 7 - 10 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Digital Health Technology (DHT)
- Pharma GxP
- ISO 9001
- ISO 13485
- ISO 27001
- CISMA
- CISA
- CRISC
- AI
- ML
- DHT
- ICH E 6(R3) GCP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Indivi and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
Not a perfect match?
- ten23 health
Head of IT(m/w/x)
Full-timeOn-siteSeniorBasel, Visp - Idorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Full-timeOn-siteSeniorBasel - Roche
Head of QA for QC(m/w/x)
Full-timeOn-siteSeniorKaiseraugst - Abbott
Ethics and Compliance Director, EPD(m/w/x)
Full-timeOn-siteSeniorAllschwil, Basel
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 7 - 10 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Digital Health Technology (DHT)
- Pharma GxP
- ISO 9001
- ISO 13485
- ISO 27001
- CISMA
- CISA
- CRISC
- AI
- ML
- DHT
- ICH E 6(R3) GCP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Indivi and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Indivi
Industry
Science
Description
Indivi is a TechBio company enabling precision and personalised medicine in neuroscience R&D.
Not a perfect match?
- Roche
Head of Compliance and Quality Governance(m/w/x)
Full-timeOn-siteSeniorKaiseraugst - ten23 health
Head of IT(m/w/x)
Full-timeOn-siteSeniorBasel, Visp - Idorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Full-timeOn-siteSeniorBasel - Roche
Head of QA for QC(m/w/x)
Full-timeOn-siteSeniorKaiseraugst - Abbott
Ethics and Compliance Director, EPD(m/w/x)
Full-timeOn-siteSeniorAllschwil, Basel