Sarah S.

About Sarah S.

Quality Assurance leader with a Lean manufacturing and Quality by Design (QbD) mindset, specializing in building and scaling GMP-compliant Quality Management Systems (QMS) that support full product lifecycle management, clinical development, and BLA readiness.I bring experience leading Quality, CMC, and cross-functional compliance strategy across R&D, Manufacturing, Regulatory Affairs, and Operations. My work aligns with FDA, ICH, and global health authority expectations—including EMA and TGA—enabling organizations to advance products efficiently while maintaining inspection-ready systems and a strong quality culture.Key areas of expertise include:Quality Leadership & Governance: Enterprise-level ownership of Quality Systems, compliance frameworks, and continuous improvement programs aligned with FDA, EMA, TGA, and ICH Q8–Q10 requirements.CMC & Product Lifecycle Strategy: Strategic QA partnership for CMC development, technology transfer, process validation, stability programs, and lifecycle management from early development through commercialization.Global GMP Compliance & Inspection Readiness: Proven success establishing and sustaining inspection-ready organizations, supporting global audits, health authority interactions, and risk-based compliance approaches.Program & Portfolio Leadership: Oversight of multiple complex initiatives across functions and geographies, balancing regulatory risk, development timelines, and business priorities.Cross-Functional & Executive Partnership: Trusted leader collaborating with multidisciplinary teams and senior leadership to translate global regulatory expectations into scalable, practical execution.I am motivated by building durable, globally compliant quality organizations that enable innovation, accelerate development timelines, and support long-term enterprise growth. I thrive in environments where Quality operates as a strategic partner and driver of organizational maturity.

Experience

1. Director of Quality Assurance

   Lumen Bioscience

   Mar 2020 — Present · Seattle, WA, US

   As Director of Quality Assurance at Lumen Bioscience, I lead the design, implementation, and oversight of a GMP-compliant Quality Management System supporting biologics development through clinical-stage advancement and BLA readiness.I provide strategic Quality leadership across R&D, Manufacturing, CMC, and Regulatory Affairs, ensuring alignment with FDA, ICH, and global regulatory expectations. My role includes establishing scalable quality infrastructure, strengthening inspection readiness, and embedding a risk-based, quality-by-design approach across the organization.Key responsibilities and impact include:Building and maintaining an enterprise-wide QMS aligned with cGMP, FDA, ICH Q8–Q10, and global regulatory standardsPartnering closely with CMC and Regulatory Affairs to support process development, technology transfer, stability programs, and lifecycle managementLeading inspection readiness, internal audits, and health authority interactions to ensure sustained complianceDriving continuous improvement initiatives to enhance quality culture, operational efficiency, and organizational maturityProviding cross-functional leadership and mentorship to support a growing, phase-appropriate biotech organizationThrough a strategic, collaborative approach, I enable Lumen Bioscience to advance innovative biologics while maintaining a strong foundation of quality, compliance, and operational excellence.

Education

• Idaho State University

  Bachelor of Arts (B.A.), Chemistry

  2002 — 2006

• Yoga Teachers College

  Certificate, Yoga Teacher Training/Yoga Therapy

  2020 — 2020

• Brigham Young University

  Master of Science, Organic Chemistry

  2006 — 2009

• ASQ

  Certificate, CQA

• University of Washington

  Certificate, Project Management