Lisa Winstead Resilience

Lisa Winstead is currently the Site Quality Head at Resilience Inc in Durham, NC. Lisa has acted as a leader of the sterility assurance and quality programs. Lisa has experience in building and managing large teams, developing, and deploying standard operating procedures and guidelines, and expertly maintaining businesses processes. She had supported GMP manufacturing, Sterility Assurance initiatives and has ensured compliance by managing the release of bulk and filled Product. Prior to her current role at the Resilience Durham site, Lisa held various leadership positions at Hospira, Pfizer, Wyeth and Human Genome Sciences.

Lisa has more than 25 years of industry experience which expands to quality management, GMP auditing, root cause analysis, CAPA verification, Quality Risk Management, GMP operations, Inspection Readiness, Product Approvals, and batch disposition. She has made significant contributions in driving operational excellence and achieving superior results regarding batch manufacturing cycle times. Lisa has consistently turned around organizations with compliance challenges. Lisa has demonstrated success in implementing Quality Management programs, Data Integrity Remediation, Product Licensure Approvals, Maturity Modeling, improving lead times and implementing remediation activities that meet regulatory requirements.

Lisa holds a B.S. degree in Biology from Saint Paul’s College, an MBA in Management from Iona College and a Master in Regulatory Science from the University of Maryland. She is also a certified Quality Auditor by the American Society of Quality and a Certified Qualified Person Liaison by David Begg & Associates.