Quality Risk Manager driving compliance programs for Redmond and Seattle biopharmaceutical sites. Enhancing the Risk Management program with cross-functional collaboration and regulatory compliance.
Responsibilities
Facilitate and coordinate formal Risk Assessments with cross functional groups to identify risks.
Work with process owners and subject matter experts to identify required mitigations and drive down risk to acceptable levels.
Manage the site risk register for both the Seattle and Redmond facilities.
Communicate major risks and the associated mitigation plans to senior management.
Continue the development and improvement of Just-Evotec Risk Management program.
Mentor and train functional groups in the area of Risk Management to increase risk intelligence within the broader organization.
Partner with both internal/external collaborators, vendors, and regulatory agencies to anticipate and resolve risk and maintain GxP compliance.
Requirements
Bachelor’s degree in biological sciences, chemistry, biochemistry, engineering, computer science or related life science field
4+ years relevant experience in Risk Management with experience working in biopharmaceutical cGMP manufacturing preferred
Knowledge of Risk Management, Data Integrity, Industry guidelines, US & EU regulatory requirements
Knowledge of risk analysis methodologies and tools (e.g. : HACCP, HAZOP, FMEA, RRF, etc.)
Benefits
discretionary annual bonus
comprehensive benefits to include Medical, Dental and Vision
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