TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures

Why do life science companies still scramble when an inspection is coming, even when their quality systems are solid on paper? Yeime Martich, a 25-year quality veteran, makes the case that readiness is a logistics and culture problem, not a documentation problem, and that the procedures you wrote may be creating more audit risk than you realize.Yeime discusses why "minimally compliant" is a discipline rather than a shortcut, how leadership shapes quality culture through what they ask about, fund, and tolerate, and why the strongest signal of a healthy quality system is when people come to quality voluntarily to report problems.A few of Yeime's key takeaways:Inspection readiness is the natural output of a healthy quality system, not something you build in the weeks before an audit"Minimally compliant" means meeting the regulatory intent without overcommitting in your procedures to things your team can't actually followQuality should come to the table with options, not just a no — release to warehouse on risk while the investigation closes, for exampleLeadership shapes culture through what they ask about, what they fund, and what they tolerateThe strongest quality culture signal: people voluntarily surfacing problems without fear of blameAI is useful for data analysis and review, but accountability for quality decisions sits with people — "AI didn't tell us" showed up in a recent FDA warning letterDesign your QMS around flexibility — rigid procedures that block product release unnecessarily are self-imposed constraints the regulation never requiredAbout Yeime MartichYeime Martich is Vice President of Quality Assurance at TerSera Therapeutics with 25 years of experience in pharmaceutical and medical device quality systems. Before TerSera, she spent over 11 years at Hospira in global compliance roles overseeing internal audit programs across international manufacturing sites, and held quality systems leadership positions at Melinta Therapeutics and Abbott.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle — from clinical development to commercialization — with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/