Quality Risk Manager, QTR - site based, Redmond, WA

Role Summary

Quality Risk Manager, QTR to join the team. Responsible for providing quality oversight of the Seattle and Redmond Risk program, ensuring program and execution are compliant with the Just Pharmaceutical Quality System and regulations. Build, facilitate, and develop solutions to identify and reduce risks at the site level.

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 internal/external collaborators, vendors, and regulatory agencies to anticipate and resolve risk and maintain GxP compliance.
• This position is field based and requires onsite support at Redmond or the Seattle facility depending on site needs.

Qualifications

• Bachelor‚Äôs 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.
• Ability to work independently and within teams; strong problem-solving skills; partner/customer focus; ability to work with complex business systems and processes.
• 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.).