Experienced and highly dedicated professional with over 25 years in regulated environments, including GLP and GCP. Proven expertise as a Lead Auditor for clinical and non-clinical programs, managing audit plans, quality inspections, and site compliance. Effective mentor and coach with deep insight into career transitions, relationship building, and stakeholder engagement. Recognized for strong communication, analytical, and organizational skills. Dynamic mentor and coach with deep insight into career transitions and professional development. Consistently successful in cultivating strong relationships across diverse individuals and organizations. Known for exceptional communication, analytical, and organizational strengths.
Proven experience hosting regulatory inspections and engaging effectively with clients during clinical trial site audits. Skilled Lead Auditor with a strong background in building and guiding audit teams to ensure thorough and compliant evaluations. Adept at leveraging professional networking and relationship-building skills to maintain client satisfaction and foster long-term partnerships. Demonstrated ability to identify deficiencies during audits and develop effective mitigation strategies to ensure regulatory compliance and continuous quality improvement. Skilled in prioritizing client needs and consistently delivering tailored solutions within established timelines.