Senior Director, Quality Assurance – FIH Site Based, Seattle, WA

Job Title: Senior Director Quality Assurance FIH

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 Quality Assurance - First-in-Human 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 this role youll have the opportunity to drive impactful projects collaborate with bright minds and explore uncharted territories.

As a Senior Director Quality Assurance - First-in-Human 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.

Position Summary

The Senior Director Quality Assurance First-in-Human (FIH) serves as the Quality strategy lead for early-phase clinical programs responsible for designing and governing a phase-appropriate Pharmaceutical Quality System (PQS) that enables rapid compliant progression from development to first-in-human studies. Reporting to the VP Global Quality Assurance this role defines the quality framework risk-based approaches and governance model required to support accelerated biologics development while maintaining alignment with global regulatory expectations.

As a member of the site leadership team this individual partners cross-functionally to ensure quality is embedded by design establishing a scalable foundation that evolves from FIH through later clinical phases without introducing unnecessary complexity or burden.

What Youll Do:

Quality Strategy & Program Leadership

• Define and implement the phase-appropriate quality strategy for FIH programs aligned with clinical development timelines and regulatory expectations.

• Establish a risk-based quality framework to enable speed while ensuring patient safety and data integrity.

• Provide strategic direction for quality governance decision-making and escalation models supporting early-phase development

• Serve as a senior quality advisor to leadership on clinical readiness regulatory expectations and risk posture.

• Will be in the future managing 8 to 10 direct reports.

Pharmaceutical Quality System (PQS) Design

• Architect and continuously refine a fit-for-purpose PQS tailored to FIH and early clinical development.

• Define core PQS elements including:

• Quality Manual and policy hierarchy

• Phase-appropriate documentation and control strategies

• Risk management frameworks

• Data Integrity and data governance principles

• Ensure the PQS is scalable and adaptable to support transition from FIH to later-stage development and aligned with global frameworks such as ICH Q10 and ICH Q9.

Regulatory Strategy & Inspection Readiness

• Define the quality narrative and strategy supporting regulatory interactions for FIH programs.

• Establish inspection readiness frameworks including storyboards and risk-based preparedness models.

• Provide strategic oversight for regulatory submissions and quality-related content supporting early-phase filings.

Audit & Oversight Strategy

• Design a phase-appropriate audit and oversight model including internal and supplier audit strategies.

• Define expectations for Data Integrity assessment audit depth and risk-based audit planning.

• Ensure alignment of audit strategy with overall PQS maturity and clinical phase requirements.

Quality Governance & Performance

• Establish quality governance structures (e.g. Quality Councils review forums) to drive visibility and accountability

• Define and monitor strategic KPIs and health indicators aligned to FIH objectives

• Drive a culture of proactive quality and risk-based decision making

Who You Are:

• Advanced degree in Life Sciences Biochemistry Biology Engineering or related field; PhD or MS preferred.

• 12 years of progressive Quality leadership experience in biologics or biopharmaceuticals; 5 years in site or departmental leadership roles.

• Deep expertise in cGMP regulations (US and EU) and phase-appropriate quality requirements for clinical biologics.

• Strong track record of inspection readiness and successful regulatory/client audit interactions.

• Deep expertise in:

• Phase-appropriate GMP expectations

• Early clinical development quality strategies

• Demonstrated experience designing and evolving Quality Systems not just executing within them

• Strong track record supporting inspection readiness and regulatory strategy

• Proven ability to influence senior stakeholders and drive alignment across functions

Key Attributes

• Hands-on and proactive leader who thrives in a fast-paced innovative have experience in managing 8 - 10 direct reports.

• Strategic thinker with the ability to translate vision into executable quality processes.

• Skilled in balancing regulatory compliance with operational agility to support rapid clinical timelines.

• Collaborative and influential partner across technical operational and corporate functions.

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. This role is site based.

• 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#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 $141120 to $193200;this is a salary 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.