Senior Drug Product Quality Manager
Job Title: Senior Drug Product Quality Manager
Location: Redmond, WA, will be visiting Seattle, WA once or twice per week, with some flexibility
Reports to: Sr. Director, Product Quality
About Us:
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 encourage, 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:
We’re looking for a passionate and curious Senior Drug ProductQuality 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 Drug ProductQuality Manager 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.
You will support our mission of advancing low-cost biotherapeutics manufacturing to improve worldwide access. TheDP-PQL is a member of the Product Quality Team within the Quality organization andis responsible forensuring the highest product quality andmaintainingadherence to all applicable regulations, standards, and guidelinesrelated to DP manufacture and release. This PQL works closely with Just-Evotec's Process & Product Design, Manufacturing Science & Technology, and Quality Control teams as well as the Client to provide assurance and oversight of technical aspects ofDPQuality throughout the lifecycle of the product. TheDP-PQL will support activities ranging from new product introduction, technology transfer, process and performance qualifications, commercialization, continuous process verification, and DP disposition.
What You'll Do:
Responsible for ensuring product quality throughout product lifecycle.
Partner with all relevant departments to ensuretimelycompletion of deliverables for NPI, tech transfer, PPQ, and CPV.
Act assinglepoint of contact for Quality issues with Client Quality organizations.
Execute DP disposition, ensuringcompliance with internal and cGMP expectationsforDrug Product batches manufactured at contracted CMOs.
Manage the QA communication and disposition process with CDMO client base.
Oversee the shipments of DS/DP to CMOs for fill/finish activities.
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 andmaintaina mindset for continuous improvement and learning.
Perform quality document review and approval asrequired.
Oversee investigations ofproduct relatedquality issues, deviations, and root cause investigations.
Support internal and client audits of the quality management systems.
Identify and escalate compliance risks associated with their area of responsibility
Participate in strategic development of Quality Systems
Travel to JEB local and international sites asrequired.
Who You Are:
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.
Drug Product experience is strongly desired
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: 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.
Are You Still Curious?
If you’ve read this far, then chances are you’ve got a curious mind—just like us. So, what are you waiting for? Take the leap and apply today. We can’t wait to see where your curiosity leads you and how it will shape the future of Just-Evotec Biologics.
Let your curiosity guide your career #BeCurious and explore the endless possibilities at Just-Evotec Biologics!
The base pay range for this position at commencement of employment is expected to be $112,560 to $154,100; this is a salary or hourly exempt or non-exempt role. Base salary offered may vary depending on the 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, 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.
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