Senior Drug Product Quality Manager

Evotec

Job Location:

Redmond, WA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 whats possible. Were on a mission to create a place where curiosity isnt just encourage 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 SeniorDrug ProductQuality Managerto 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 SeniorDrug ProductQuality Managerat 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.

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-Evotecs 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 Youll 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 as.
Oversee investigations ofproduct relatedquality issues deviations and root cause investigations.
Support internal and client audits of the quality management systems.
Identifyand escalate compliance risks associated with their area of responsibility
Participatein strategic development of Quality Systems
Travel to JEB local and international sites as.

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.
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: 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 box we 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 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 $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.

Required Experience:

Manager

Job Title: Senior Drug Product Quality ManagerLocation: Redmond WA will be visiting Seattle WA once or twice per week with some flexibilityReports to: Sr. Director Product QualityAbout Us: At Just-Evotec Biologics we believe that curiosity is the spark that drives innovation and success. As a forwar...