Director of Raw Materials Quality - Site , Redmond, WA

Position: Director of Raw Materials Quality - Site Based, Redmond, WA
Job Title:

Director, Raw Materials Quality

Location:

Site Based, Redmond, WA with some travel to Seattle Site.

Shifts:

Monday to Friday, Days.

About Us:

this is who we areAt Just Evotec Biologic, 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.

Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you!

The Role:

/ your challenge, …in our journey

We’re looking for a passionate and curious Director, Raw Materials Quality 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 Director, Raw Materials Quality at Just Evotec Biologic, 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 Director, Raw Materials Quality provides leadership and oversight for the raw material lifecycle quality program supporting GMP manufacturing of biologics. This role is responsible for ensuring that raw materials used in manufacturing meet all applicable regulatory, quality, and internal requirements through effective oversight of raw material testing, material disposition, and supplier quality management.

The Director leads teams responsible for incoming raw material testing, supplier qualification and monitoring, and QA disposition activities. This role partners cross-functionally with Manufacturing, Supply Chain, Quality Assurance, and Regulatory to ensure reliable and compliant raw material supply for clinical and commercial programs.

What You’ll Do:

Leadership and Functional Oversight Lead the Raw Materials Quality function, including:

QC Raw Materials Testing Raw Material Lot Disposition Supplier Quality Management Manage and develop managers and team leads responsible for day-to-day operations.

Ensure effective execution of raw material quality activities in support of manufacturing timelines.

Establish and monitor functional goals, KPIs, and performance metrics.

Promote a culture of quality, accountability, and continuous improvement.

Escalate quality, compliance, and supply risks to senior leadership as appropriate.

Raw Material Quality Program Execution Implement and maintain robust processes for:

Raw material qualification

Supplier qualification and monitoring

Incoming material sampling and testing

Raw material lot disposition

Ensure risk-based approaches to raw material control are applied in alignment with regulatory expectations.

Support development and lifecycle management of raw material specifications and control strategies.

Drive continuous improvement in raw material quality, reliability, and testing turnaround times.

QC Raw Materials Testing Oversight Provide oversight of QC raw material testing activities to ensure compliance with GMP requirements.

Ensure materials are sampled, tested, and reviewed according to approved procedures and timelines.

Oversee analytical testing programs (e.g., compendial and instrumental methods such as FTIR, HPLC, pH, etc.).Ensure analytical methods are qualified or verified as required.

Ensure timely resolution of QC investigations (e.g., OOS, deviations, atypical results).Oversee external laboratory testing where applicable.

Raw Material Lot Disposition Oversee QA disposition of raw materials to ensure compliance with cGMP requirements.

Ensure timely release of materials to support manufacturing operations.

Ensure appropriate review of:

Certificates of Analysis Supplier documentation

Analytical testing results

Qualification status

Ensure disposition decisions are properly documented within quality systems.

Supplier Quality Management Lead Supplier Quality…