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About the role
- Quality Risk Manager facilitating risk assessments and maintaining compliance in biopharmaceutical manufacturing. Collaborating with cross-functional teams at Just Evotec Biologics in Redmond, WA.
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
- short-term and long-term disability
- company paid basic life insurance
- 401k company match
- flexible work
- generous paid time off
- paid holiday
- wellness and transportation benefits
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