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

Job Title: Senior Director, Quality Assurance – FIH

We’re looking for a passionate and curious Senior Director, Quality Assurance – First‑in‑Human 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 Director, Quality Assurance – First‑in‑Human 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.

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.

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

• 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…