Quality Risk Manager, QTR

Cyprotex•Redmond, WA

23h•Hybrid

About The Position

At Just Evotec Biologics, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged—it’s celebrated. The Role: Your challenge …in our journey We’re looking for a passionate and curious Quality Risk Manager, QTR to join our team. If you’re excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. As a Quality Risk Manager, QTR at Just Evotec Biologics, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team. 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.)

Nice To Haves

A curious problem-solver with a passion for learning and growing in a dynamic environment.
Someone who is not satisfied with “just good enough” and is always looking to improve, adapt, and innovate.
A natural collaborator who loves sharing ideas and learning from others.
Comfortable with ambiguity and thrives in environments where curiosity and experimentation are encouraged.
Excellent communicator, both verbally and in writing, able to share complex ideas in a simple, relatable way.
A self-starter who takes initiative, owns your projects, and actively seeks out new challenges.

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.