Quality Risk Manager, QTR (Redmond/Seattle site support; Hybrid or remote; MonโFri days)
Responsibilities
- Facilitate and coordinate formal risk assessments with cross-functional groups.
- Partner with process owners and SMEs to identify mitigations and reduce risk to acceptable levels.
- Manage the site risk register for Seattle and Redmond.
- Communicate major risks and associated mitigation plans to senior management.
- Continue development and improvement of the risk management program.
- Mentor/train functional groups to increase organizational risk intelligence.
- Partner with internal/external collaborators, vendors, and regulatory agencies to anticipate/resolve risks and maintain GxP compliance.
- Field-based role requiring onsite support at Redmond or Seattle as needed.
Qualifications
- Bachelorโs degree in biological sciences, chemistry, biochemistry, engineering, computer science, or related life science.
- 4+ years relevant risk management experience; biopharmaceutical cGMP manufacturing experience preferred.
- Knowledge of risk management, data integrity, industry guidelines, and US & EU regulatory requirements.
- Knowledge of risk analysis methodologies/tools (e.g., HACCP, HAZOP, FMEA, RRF).
- Strong problem-solving, independent and team work, customer/partner focus, and ability to work with complex processes.
Benefits
- Base pay range: $92,400โ$135,000; discretionary annual bonus.
- Medical, Dental, Vision; short- and long-term disability; basic life insurance; 401(k) match; flexible work; generous paid time off and paid holidays; wellness and transportation benefits.