Mark Ambrose, Ph.D., has been appointed senior director of Quality Systems and Compliance at Cytovance Biologics and Anne Garstka has been named director of Commercial Compliance.
Dr. Ambrose has 20 years of quality experience and previously served as vice president of Quality at Nuron Biotech in Exton, PA, where he was responsible for quality leadership including GMP, GCP, GDP and GLP and the development and implementation of quality systems to support clinical and commercial products. He also served as the acting head of Regulatory Affairs.
Prior to Nuron Biotech, Dr. Ambrose served as Quality Operations product leader and director of sustainable compliance at Wyeth Biotech, now Pfizer. In these capacities, he was responsible for global product quality for Pfizer's Meningitec vaccine including formulation and implementation of life cycle product quality strategies.
Ms. Garstka brings 15 years of quality and compliance management experience and previously served as director of Quality Assurance and Compliance for Neos Therapeutics, where she developed and implemented quality policies to ensure compliance and modified and maintained quality systems to meet changing industry guidelines. Ms. Garstka was also a Quality Assurance manager at Celgene Celluar Therapeutics, where she was responsible for developing and maintaining quality systems to meet industry requirements for a pharma development/clinical manufacturing center.
"We are very fortunate to welcome such seasoned professionals to the Cytovance Quality team," said Maria Lopez, vice president of Quality for Cytovance Biologics. "Mark's experience with CMO/client relationships and Anne's experience in working side-by-side with internal and external customers will be tremendous assets to the Company. Their combined wealth of knowledge will allow Cytovance to expedite process and system improvements so that we can become even better partners with our clients."