Senior Product Quality Technical Manager

Evotec • Redmond, WA

1d

About The Position

We’re looking for a passionate and curious Senior Product Quality Technical Manager 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 Product Quality Technical Manager at Just-Evotec, 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. 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 Just’s 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.

Requirements

• Bachelor's degree Life/Health Sciences; master’s 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 .
• Knowledge of FDA, EMA and MHRA regulations and guidelines.
• 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.

Nice To Haves

• Experience at CDMO a plus.
• Experience with biosimilar filings a plus.

Responsibilities

• 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.

Benefits

• 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.
• Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
• Innovative Projects: You’ll 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 don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level