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

Just-Evotec Biologics•Seattle, WA

3d•Onsite

About The Position

At Just Evotec Biologics, curiosity is the spark that drives innovation and success. The company fosters an environment where challenging the status quo, learning from each other, and pushing the boundaries of what’s possible is celebrated. They are looking for a passionate and curious Senior Director, Quality Assurance - First-in-Human to join their team. This role offers the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories, where curiosity will fuel both personal growth and team success. 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.

Requirements

Advanced degree in Life Sciences, Biochemistry, Biology, Engineering, or related field.
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.
Hands-on and proactive leader who thrives in a fast-paced, innovative environment.
MUST 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.

Nice To Haves

PhD or MS preferred

Responsibilities

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.
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.
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.
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.
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.

Benefits

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.
Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life.
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.
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
Paid holiday
Wellness benefits
Transportation benefits