Director, Quality Control

Job Title: Director, Quality Control 

Location: Redmond, WA (onsite)                                 

Department: Quality Control

Reports To: VP, Global Quality Control

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 Director, Quality Control 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, Quality Control 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 position requires strong management and leadership skills as well as a deep understanding of biologics analytical GMP testing of clinical and commercial drug substance and drug product biological products, GMP raw materials inspection and release, and facility environmental monitoring programs. A proven track record of technical skills in these areas, as well as experience leading groups of QC scientists is required. 

What You’ll Do:

• Provide direction for analytical, microbial, and sample management groups to ensure timely testing.

• Develop method transfer and phase appropriate qualification/validation of analytical methods from Analytical Development to QC as well as the transfer and validation of methods between manufacturing sites.

• Ensure success of Quality Control functions through strategic and day-to-day leadership.

• Develop and maintain strategic plan, including outsourced activities and business continuity, to ensure cGMP testing needs are met.

• Responsible for QC audit and inspection readiness, including support and preparation of responses to observations and ensuring response CAPAs are effective.

• Identify gaps, design collaborative solutions and provide guidance for laboratory efficiencies and improvements.

• Planning, coordination, and continuous improvement of methods, processes, and systems to assure the quality of testing.

• Provide input and change management for quality improvements affecting QC methods and processes.

• Development and implementation of testing-related Quality Management System processes. Create, maintain, and revise QC SOPs and strategy documents that support the Quality Management System.

• Establish clear expectations, develop metrics and key performance indicators to monitor performance and ongoing activities; includes meeting and exceeding internal stakeholder and customer expectations.

• Hire, build and maintain expertise in the QC organization, through development of staff to ensure that the QC organization supports manufacturing operations and analytical development activities as required.

• Provide technical expertise during laboratory investigations such as CAPA, OOS and OOT.

• Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT and team milestones are achieved. 

Who You Are:

• BS or higher degree in relative scientific discipline with 12+ years of industry experience and 5+ years hands-on experience managing a cGMP QC laboratory, including analytical method and testing lifecycle from development through commercial drug product testing.

• Thorough understanding of phase appropriate global cGMP regulations for release and stability testing of biological products.

• Regulatory inspection and commercial product launch experience.

• Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA) as they relate to drug substance biological manufacturing and release / stability testing.

• Extensive knowledge of GMPs and DS/DP multi-compendial assays (USP, EP, JP) and understanding of biologics manufacturing processes