Dawn Lundin
Vice President of Global Quality @Lykos Therapeutics
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WORK HISTORY
Vice President of Global Quality @Lykos Therapeutics
San Jose, CA, US
Set the strategy and design of the quality management system in support of future market approvals of psychedelics for mental health treatments. Oversee quality and compliance governance updates for EC and the board. Responsible for hosting health authority inspections and advising leaders and stakeholders (clinical sites, IIT sponsors, Expanded Access sites, advisory committees) on risk based quality management and innovative quality by design approaches to support regulatory compliance. Manage staff providing quality oversight of vendors and contract manufacturing. Support general counsel with corporate policies, privacy, and compliance programs. Accountable for quality and IT departmental budgets. Support diligence and engagements with investors to secure and sustain successful series A and B funding.
EDUCATION
Delaware Valley University
BS, Biology
Temple University
MS, Quality Assurance and Regulatory Affairs
ABOUT DAWN LUNDIN
Recognized executive leader in quality management and compliance across pharmaceutical, biotech, and academic environments. Over 29 years of experience in quality system design and risk- based quality management from clinical development through commercial. Fully engaged in innovative approaches to quality by design and expert in risk-based quality management as an enabler to regulatory compliance. Key competencies include- lead vision and strategy to design the first QMS for a novel modality in the start-up environment - developed and promoted the first Research Quality Manual and issues management program in the large pharmaceutical environment - supported diligence and investor engagements to secure series A and B funding rounds of $100 million each - dedicated to continuing education of RBQM as an enabler to compliance through faculty appointments and external engagements
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