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

Evotec • Redmond, WA

3d • Onsite

About The Position

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.)

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

• Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.
• Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life.
• Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
• Innovative Projects: You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
• A Place for Big Ideas: We don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees