Quality Risk Manager, QTR
Evotec•Redmond, WA
•Hybrid
About The Position
The Site Quality Risk Manager, for the Redmond and Seattle sites reports to the Sr. Manager of the Quality Technical and Risk (QTR) department. This position is responsible for providing quality oversight of the Seattle and Redmond Risk program. Ensuring that the program and execution are fully compliant with the Just Pharmaceutical Quality System (PQS) and regulations. This role will partner to build, provide guidance, facilitate and develop solutions to identify and reduce risks at the site level.
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.
- Be able to successfully work independently and within teams, demonstrate strong problem-solving skills, partner/customer focus, and the 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.)
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.
- This position is field based and requires onsite support at Redmond or the Seattle facility depending on site needs.
Benefits
- Medical
- Dental
- 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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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
