Cheryl Kitchen Email & Phone Number

Cheryl KitchjenQuality Assurance Director | Cell and Gene Therapy | LonzaEnsuring Compliance, Driving Excellence, and Mitigating RisksProven leader with over 25 years of experience in quality assurance within the pharmaceutical industry. Skilled in developing and implementing robust quality systems to meet regulatory requirements and exceed industry standards.Expertise Highlights:- Quality Management:Spearheading comprehensive quality programs to ensure adherence to cGMP, FDA, ISO and other regulatory standards.- Compliance Assurance:Driving compliance initiatives, audits, and inspections to maintain regulatory compliance and mitigate risks.- Process Optimization: Identifying opportunities for process improvements and efficiency enhancements to streamline operations while maintaining quality.- Team Leadership: Building and leading high-performing quality teams, fostering a culture of accountability, collaboration, and continuous improvement.- Cross-functional Collaboration: Collaborating closely with R&D, Manufacturing, Regulatory Affairs, and other departments to ensure seamless integration of quality initiatives throughout the product lifecycle.Career Highlights:- Led successful FDA inspections resulting in zero observations. - Utilized Six Sigma tools to streamline batch release process to significantly reduce batch release cycle time, from average 93 days to average 25 days- Developed and executed training programs resulting in improved quality awareness and compliance across the organization.