Sr. Director of Product Quality - Redmond,WA
Sr. Director of Product Quality - Redmond,WA
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Job Description
Job Title: Senior Director of Product Quality
Location: Redmond WA
Department: Quality Assurance
Reports To: Vice President Global Quality Assurance
About Us: this is who we are
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 encouragedits 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: Your challenge in our journey
Were looking for a passionate and curious Senior Director of Product Quality 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 fit. In this role youll have the opportunity to drive impactful projects collaborate with bright minds and explore uncharted territories.
As a Senior Director of Product Quality at 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.
What Youll Do:
Leadership & Team Management
- Directly manage and develop a global team of Product Quality Leads.
- Foster a high-performance culture centered on proactive quality management operational excellence and professional development.
Global Product Quality Oversight
- Lead the Global Product Quality function to support product lifecycle management from development through commercial supply.
- Ensure alignment with regulatory requirements client expectations and internal quality standards.
Client & Stakeholder Engagement
- Serve as the single point of contact for product quality matters with client Quality organizations.
- Maintain strong relationships with internal stakeholders including Quality Assurance Process Development MSAT Regulatory Affairs and Operations.
New Product Introduction (NPI) & Tech Transfer
- Ensure the timely execution of NPI quality deliverables in collaboration with internal Quality teams.
- Support the development and continuous improvement of SOPs and quality systems relevant to NPI and tech transfer activities.
Process Validation & Quality Systems
- Partner with Process Development and MSAT to develop and maintain a robust process validation program.
- Provide oversight and guidance for investigations into product-related deviations out-of-specifications (OOS) and root cause analysis.
- Review and approve quality documents such as deviations CAPAs change controls and protocols as required.
Quality Governance & Continuous Improvement
- Contribute to and support Quality Management Reviews (QMRs) driving data-driven decisions and quality performance improvements.
- Lead initiatives that promote a culture of quality and compliance across the organization.
Travel
- Travel to domestic and international internal sites and client locations as required.
Who You Are:
- A Ph.D. Masters or Bachelors degree in a relevant scientific or engineering discipline (e.g. Biochemical Engineering Biotechnology Chemical Engineering or related field).
- Extensive experience (typically 10 years) in biopharmaceutical manufacturing process/product development MSAT QC or QA. Experience at CDMO a plus.
- Previous leadership experience in a managerial or directorial capacity within a pharmaceutical or biotech company.
- In-depth knowledge of current Good Manufacturing Practices (cGMP) and regulatory guidelines pertaining to biopharmaceutical manufacturing. Experience with biosimilar filings a plus.
- 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.
- Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life whether that means working remotely or choosing a hybrid model.
- 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 mindjust like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads youand how it will shape the future of Just Evotec Biologics
Let your curiosity guide your career#BeCUREious and explore the endless possibilities at Just Evotec Biologics!
The base pay range for this position at commencement of employment is expected to be $141120 to $193200; 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 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.
Required Experience:
Director
Employment Type
Full-Time
