Quality Risk Manager

Location : Hybrid; Willing to travel to the US and within Europe

Industry : Life Science

Join a global company in the Life Science industry seeking an experienced Quality Risk Management Lead with a deep understanding of Computer System Validation, GxP compliance, and IT Quality Operations. This role is ideal for someone with a strong foundation in IT Quality Analysis or Operations Quality.

Key Responsibilities :

• Lead and execute Quality Risk Assessments across GxP systems and processes.
• Apply knowledge of TrackWise Digital, SharePoint, and other QMS tools to facilitate effective QRM practices.
• Develop and implement risk mitigation strategies aligned with business and regulatory expectations.
• Provide valuation and impact analysis of identified risks, ensuring alignment with corporate risk tolerance levels.
• Design and deliver training programs and workshops to educate business stakeholders on risk awareness and best practices.

Requirements :

• Strong expertise in CSV, GMP, GxP, and IT Quality Operations.
• Hands-on experience with risk assessment frameworks and compliance tools (e.g., TrackWise Digital, SharePoint).
• Excellent understanding of regulatory requirements such as ICH Q9, FDA guidelines, and other international standards.
• Familiarity with QMS and LIMS platforms.
• Background in IT quality analysis or operations quality with progression into Audit and Compliance.
• Proven ability to lead workshops, train stakeholders, and drive cross-functional risk management initiatives.
• Strong communication, documentation, and stakeholder engagement skills.

Interested in learning more? Please reach out to me via message or email me (emailprotected)

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