Demonstrated ability to apply comprehensive, in-depth, understanding of pharmaceutical industry regulatory compliance requirements with an emphasis on GMP/GLP/GCP related issues, and related US and international laws.
July 26, 2021
Participate in the development of internal and external GLC/GCP/GVP annual audit plan for sites and vendors and update the audit plan as needed based on identified risks and trial priorities.
July 29, 2021
Lead, and/or conduct/support (in collaboration with GMP QA colleagues), global Good Pharmacovigilance Practice (GVP) Audits of systems and processes related to clinical and post-market patient safety information collection, evaluation and reporting.
August 02, 2021
Development of short and long-term risk-based quality strategies in support of M&D development programs based on current regulatory interpretations, and drives their implementation locally and globally as appropriate.
September 04, 2021
Support process transfer and process engineering of retroviral replicating vectors (RRV) platform products including process optimization, new product implementation, process transfer, scale-up, validation, risk analysis process characterization and troubleshooting.
November 27, 2021
Assistant Directors of Enrollment Services, and the Assistant Directors of Student Recruitment and/or Enrollment are educated and trained properly to create the best prospective learner service possible and to ensure that the team is equipped with the processes and knowledge to increase efficiency through the sales cycle.
January 14, 2022
Manage batch release activities for clinical production including but not limited to review of batch records, analytical data with emphasis on the effect of safety and/or efficacy impact to the clinical study, certificates of analysis, evaluation of the IND and other documents.
January 27, 2022