Senior Director, Quality Assurance – FIH - Site Based, Seattle, WA
Evotec WD, Seattle, WA, United States
**Job Title:**
Senior Director, Quality Assurance – FIHAs 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.* 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.* 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.* 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* 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.* **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. This role is site based.* **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.
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Senior Director, Quality Assurance – FIHAs 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.* 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.* 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.* 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* 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.* **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. This role is site based.* **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.
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