Senior Product Quality Manager

Senior Product Quality Manager Redmond, WA (with some travel to Seattle, WA)

Just-Evotec Biologics is seeking a highly motivated Senior Product Quality 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.

 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.

Qualifications 

• 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. 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. 

The base pay range for this position at commencement of employment is expected to be $111,360 to $152,425; Base salary offered may vary depending on individual’s 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.