Sara is a dynamic senior biopharma operations and quality leader with over 15 years of experience in GMP manufacturing, regulatory readiness, and enterprise execution. She brings deep expertise across manufacturing operations, quality systems, sterility, and PMO leadership, supporting organizations from early clinical development through commercial launch.

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Sara has led and advised on high-stakes initiatives including manufacturing facility expansions, greenfield and brownfield builds, PPQ and EMPQ readiness, audit remediation, and operational scaling in both biopharma and radiopharma environments. She is frequently engaged as a trusted subject matter expert for FDA and QP inspections, capital project decision-making, and compliance risk mitigation.

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In her role, Sara partners closely with project teams and executive leadership to translate complex technical and regulatory challenges into clear, actionable strategies. She is known for her ability to align quality, manufacturing, and business objectives to help organizations achieve audit success, operational readiness, and sustainable growth.  Her passions and strengths align to drive operational efficiencies by implementing metrics, visual management tools, and tracking and trending processes.

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Previously, Sara held progressive leadership roles at Cognate BioServices (Charles River Laboratories), where she directed large-scale manufacturing operations, led PPQ execution, managed $10M+ operating budgets, and scaled teams and cleanroom capacity to support rapid portfolio expansion. Earlier in her career, she built a strong foundation in sterility assurance, validation, and nuclear engineering within highly regulated medical device and industrial environments.

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Sara combines hands-on technical credibility and out-of-the-box creative thinking with an executive-level perspective, making her a valued advisor for organizations navigating regulatory scrutiny, operational complexity, and  process improvement challenges.