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

Role Summary

Quality Risk Manager, QTR to join our team. You’ll drive impactful projects, collaborate with bright minds, and explore uncharted territories. The role involves quality risk oversight for the Redmond/Seattle sites, ensuring compliance with PQS and regulations, and partnering to identify and reduce site-level risks.

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.
• Field-based role with onsite support at Redmond or Seattle facility depending on site needs.

Qualifications

• A curious problem-solver with a passion for learning and growing in a dynamic environment.
• Someone who strives to improve, adapt, and innovate; collaborative mindset.
• Excellent verbal and written communication; ability to simplify complex ideas.
• Self-starter with initiative and project ownership.
• Bachelor‚Äôs degree in biological sciences, chemistry, biochemistry, engineering, computer science or related life science field.
• 4+ years of relevant experience in Risk Management, preferably in biopharmaceutical cGMP manufacturing.
• Ability to work independently and within teams; strong problem-solving skills; customer-focused; proficient 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).

Skills

• Risk management and mitigation planning
• Cross-functional collaboration
• Regulatory compliance (GxP)
• Data analysis and risk assessment methodologies
• Effective communication and training

Education

• Bachelor‚Äôs degree in biological sciences, chemistry, biochemistry, engineering, computer science or related life science field

Additional Requirements

• Onsite presence at Redmond or Seattle facility as required by site needs