Senior Product Quality Technical Manager

Job Title: Senior Product Quality Technical Manager

Location: Redmond WA

Reports to: Sr. Director Product Quality

About Us:

At Just-Evotec 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 encouraged its 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:

Were looking for a passionate and curious Senior Product Quality Technical Manager to 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 this role youll have the opportunity to drive impactful projects collaborate with bright minds and explore uncharted territories.

As a Senior Product Quality Technical Manager at Just-Evotec 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.

Just-Evotec Biologics is seeking a highly motivated Senior Product Quality Technical Manager who will function as a Product Quality Lead (PQL) to support our mission of advancing low-cost biotherapeutics manufacturing to improve worldwide access. The PQL is a member of the Product Quality Team within the Quality organization and is responsible for ensuring the highest product quality and maintaining adherence to all applicable regulations standards and guidelines. This PQL works closely with Justs Process & Product Design Manufacturing Science & Technology and Quality Control teams as well as the Client to provide assurance and oversight of technical aspects of Quality throughout the lifecycle of the product. The PQL will support activities ranging from new product introduction technology transfer process and performance qualifications commercialization and continuous process verification.

What Youll Do:

• Responsible for ensuring product quality throughout product lifecycle
• Partner with all relevant departments to ensure timely completion of deliverables for NPI tech transfer PPQ and CPV.
• Act as single point of contact for Quality issues with Client Quality organizations.
• Maintain strong relationships with multiple internal and external team members and cross functional groups.
• Support the development and/or improvement of SOPs related to PQL activities and maintain a mindset for continuous improvement and learning.
• Perform quality document review and approval as required.
• Oversee investigations of product related quality issues deviations and root cause investigations.
• Travel to JEB local and international sites as required.

Who You Are:

• Bachelors degree Life/Health Sciences; masters degree and/or Ph.D. a plus.
• Minimum 10 years experience in biopharmaceutical or related industries in manufacturing Product Development or MSAT QC or QA . Experience at CDMO a plus.
• Knowledge of FDA EMA and MHRA regulations and guidelines. Experience with biosimilar filings a plus.
• Excellent verbal and written communication skills.
• Knowledge of QMS and CAPA related processes and systems is required.
• Ability to work across functional areas and foster a collaborative culture of quality within the organization.
• Experience with NDA and/or BLA submissions and Inspection readiness for Sponsors is strongly desired.

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.
• 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 mind just like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads you and how it will shape the future of Just-Evotec.

Let your curiosity guide your career #BeCurious and explore the endless possibilities at Just-Evotec.

This job description is intended to describe the general content of the job and to identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties responsibilities or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business this description is subject to change and may be modified at any time whether formally or informally.

The base pay range for this position at commencement of employment is expected to be $112560 to $154100;this is a salary or hourly exempt or non-exempt role. 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 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.