Sheri Winkels
Senior Director of Quality & Compliance Vyriad
Sheri Winkels is a veteran leader in the development, promotion, and implementation of quality and operational practices supporting pharmaceutical, biological, and cell and gene therapy industries. With more than 45 years of experience, Sheri’s expertise spans a range of topics, including phase-appropriate compliance, strategic product management, operational excellence, and integration of quality into fast growing or highly regulated environments. Sheri’s career has focused on cultivating strong relationships and educating teams on sound quality management systems and robust regulatory compliance. Her contributions continue to influence best practices in pharmaceutical and advanced therapy manufacturing, helping organizations achieve sustainable quality outcomes and regulatory success.
Seminars
- Minimizing variability in packing, documentation, and procedures to lower training burdens, reduce liability, and decrease error risk
- Standardizing chain of identity and chain of custody practices to improve interoperability across sponsors, logistics providers, and clinical sites
- Designing processes around patient and site realities with clearer, more consistent expectations for storage, transportation, and digital workflows
- Adopting hub or network-based models to reduce portal fatigue whilst accommodating site-specific operations
- Providing shared visibility across logistics, manufacturing, and clinics to support compressed vein-to-vein timelines (<14 days) and accelerate therapy delivery
- Leveraging commercially available digital tools for adoption in new and community-based sites
