Robyn Durr-Henry

About Robyn Durr-Henry

I am an experienced and passionate Quality Assurance and regulatory professional that holds a Master of Science degree in Regulatory Affairs with a focus on drugs, medical devices and biologics. I also have a Registered Quality Professional (RQAP-GLP) certification that I have maintained for the past 17 years. I have a strong background and professional working history in the compliance and quality oversight of all aspects of regulated projects (FDA GLP, OECD GLP, GCP, ICH, VICH) supporting regulatory submissions throughout all phases of drug and product development for human and animal health. I have a desire and passion to- cultivate and expand the quality culture of an organization-facilitate and provide quality oversight of robust risk management strategies and implementation of quality by design strategies for the R&D organization-provide business key performance indicators to assess and address compliance risks and trends-develop and maintain a robust quality management system that assures data integrity is maintained-develop and support members of the quality organization- and balance the requirements of regulation with business needs to support continuity. I have been in the compliance industry for over 20 years and have built a solid foundation of regulatory compliance experience and expertise from a CRO and pharmaceutical company perspective.

Experience

1. Director Quality and Compliance

   Clinglobal

   May 2022 — Present · US

   Oversee and facilitate quality and compliance for successful execution of safety and efficacy studies. Support and lead compliance strategies for global company to allow for streamlined and compliant study execution. Review and revise Quality Management Systems to reflect current regulatory expectations. Grow and foster a holistic Quality culture.

Education

• Florida Agricultural and Mechanical University

  Biology

• Northeastern University

  Master's degree, Regulatory Affairs

Skills

• Regulatory Affairs
• 21 Cfr Part 11
• CRO
• Medical Devices
• U.s. Food and Drug Administration (Fda)
• Biotechnology
• Quality Assurance
• Pharmaceutical Industry
• Sop
• Fda
• Standard Operating Procedure (Sop)
• Validation
• Computer System Validation
• Regulatory Submissions
• Drug Discovery
• Good Laboratory Practice (Glp)
• Toxicology
• Clinical Trials
• Quality Auditing
• Drug Development
• Bioanalysis
• Glp
• Protocol
• Life Sciences
• Ind