Contract position
Start date: May
Duration: December 2025 + extensions
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 yherrera@itrustpartnering.com