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 whats possible. Were on a mission to create a place where curiosity isnt just encouragedits celebrated.

Are you someone who asks questions seeks answers and isnt afraid to go deeper #BeCUREious with us and see where your curiosity can take you!

The Role: Your challenge in our journey

Were looking for a passionate and curious Director Quality Controlto join our team. If youre excited by new challenges solving complex problems and learning every step of the way you might just be the perfect fit. In this role youll have the opportunity to drive impactful projects collaborate with bright minds and explore uncharted territories.

As a Director Quality Controlat Just Evotec Biologics youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its 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 Youll 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.

• Experience with the operation deployment and administration of laboratory information. management systems (LIMS) and other GMP electronic systems.

Preferred Qualifications:

• Entrepreneurial drive to achieve business objectives.

• Contract laboratory experience.

• Knowledge and expertise to solve complex technical and process problems.

• Training and certification in Lean Six Sigma methodology.

Why Join Us:

• Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.

• Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life whether that means working remotely or choosing a hybrid model.

• Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.

• Innovative Projects: Youll 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 dont just talk about thinking outside the boxwe throw the box away. If youve got ideas we want to hear them.

Are You Still Curious

If youve read this far then chances are youve got a curious mindjust like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads youand how it will shape the future of Just Evotec Biologics

Let your curiosity guide your career#BeCUREious and explore the endless possibilities at Just Evotec Biologics!

The base pay range for this position at commencement of employment is expected to be $141120 to $193200;Base salary offered may vary depending on the individuals skills experience and competitive market value. Additional total rewards include discretionary annual bonus comprehensive benefits to include Medical Dental and Vision short-term and long-term disability company paid basic life insurance 401k company match flexible work generous paid time off and paid holiday wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race gender age disability genetic information gender expression gender identity national origin religion sexual orientation or veteran status.