Sr. Director of Product Quality - Redmond,WA

Job Title:

Senior Director of Product Quality

Location:

Redmond, WA
Department:
Quality Assurance

Reports To:

Vice President, Global Quality Assurance

About Us:

this is who we are

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.

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 Senior Director of Product 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 Senior Director of Product Quality 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.

What You’ll Do:

Leadership & Team Management

• Directly manage and develop a global team of Product Quality Leads.

• Foster a high-performance culture centered on proactive quality management, operational excellence, and professional development.

Global Product Quality Oversight

• Lead the Global Product Quality function to support product lifecycle management from development through commercial supply.

• Ensure alignment with regulatory requirements, client expectations, and internal quality standards.

Client & Stakeholder Engagement

• Serve as the single point of contact for product quality matters with client Quality organizations.

• Maintain strong relationships with internal stakeholders including Quality Assurance, Process Development, MSAT, Regulatory Affairs, and Operations.

New Product Introduction (NPI) & Tech Transfer

• Ensure the timely execution of NPI quality deliverables in collaboration with internal Quality teams.

• Support the development and continuous improvement of SOPs and quality systems relevant to NPI and tech transfer activities.

Process Validation & Quality Systems

• Partner with Process Development and MSAT to develop and maintain a robust process validation program.

• Provide oversight and guidance for investigations into product-related deviations, out-of-specifications (OOS), and root cause analysis.

• Review and approve quality documents such as deviations, CAPAs, change controls, and protocols as required.

Quality Governance & Continuous Improvement

• Contribute to and support Quality Management Reviews (QMRs), driving data-driven decisions and quality performance improvements.

• Lead initiatives that promote a culture of quality and compliance across the organization.

Travel

• Travel to domestic and international internal sites and client locations as required.

Who You Are:

• A Ph.D., Master's, or Bachelor’s degree in a relevant scientific or engineering discipline (e.g., Biochemical Engineering, Biotechnology, Chemical Engineering, or related field).

• Extensive experience (typically 10+ years) in biopharmaceutical manufacturing, process/product development, MSAT, QC or QA. Experience at CDMO a plus.

• Previous leadership experience in a managerial or directorial capacity within a pharmaceutical or biotech company.

• In-depth knowledge of current Good Manufacturing Practices (cGMP) and regulatory guidelines pertaining to biopharmaceutical manufacturing.

Experience with biosimilar filings a plus.

• Experience with NDA and/or BLA submissions and inspection readiness for Sponsors is strongly desired.

Why Join Us:

• 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…