Director Of Quality

• Jun 2021 - Present

Quality Assurance Manager

• Mar 2020 - Present

Independent Consultant

• Jun 2018 - Present

Founded consulting firm with the goal of providing efficient quality clinical trials in a cost-effective manner for clients within the US ♦ Identify and prepare due diligence questionnaires for CROs to perform clinical trials of dietary supplements ♦ Conduct on-site due diligence of multiple CROs in India ♦ Inspect clinical sites for adherence to GCP, GMP, and ICH guidelines ♦ Evaluate EDC systems and CRFs to ensure compliance and data authenticity ♦ Perform SWAT analysis of both technical and financial implications of Indian CROs for US clientele ♦ Finalize and recommend the CROs and prepare RFPs Show less

Quality Specialist

• Oct 2008 - May 2018

♦ Led and managed 24 projects ♦ Reduced non-conformances in supported areas by proactively driving compliance, and conducting internal audits and regulatory inspections ♦ Designed quality systems for clinical and non-clinical sample analysis ♦ Reviewed BLA documents & regulatory queries in support of regulatory submissions ♦ Audited Pharmacokinetic & Pharmacometrics data and reports in support of both the IND and BLA filings ♦ Improved efficiency through reducing redundant tasks and utilized advanced skills in REDSTAR, eCTD & VeevaVault platforms for regulatory filings ♦ Reviewed Module 2, Module 3, and Module 4 documents for regulatory submissions. Show less

Senior Training Coordinator, Business Process improvement and Compliance

• 2007 - 2008

♦ Orchestrated GLP, GCP & GMP training programs for QA auditors and new hires, on a global scale ensuring consistent auditing practices ♦ Authored 30+ new SOPs while eliminating redundant ones for the Dose Formulation and the Dose Analysis group ♦ Performed on-site audits of the vendor sites for both the Pre-Clinical and Clinical programs ♦ Hosted on-site FDA facility inspection over a 3-day period, ensuring quality assurance and completed the FDA audit with high achievement ♦ Orchestrated GLP, GCP & GMP training programs for QA auditors and new hires, on a global scale ensuring consistent auditing practices ♦ Authored 30+ new SOPs while eliminating redundant ones for the Dose Formulation and the Dose Analysis group ♦ Performed on-site audits of the vendor sites for both the Pre-Clinical and Clinical programs ♦ Hosted on-site FDA facility inspection over a 3-day period, ensuring quality assurance and completed the FDA audit with high achievement

Associate Scientist, Exploratory Group

• 1999 - 2001

♦ Transitioned 20+ studies to the CRO site, operating as the primary liaison in the business outsourcing unit ♦ Administered GLP compliant method development and validation for multiple key compounds (using HPLC) ♦ Established data authentication system and eliminated vendor manipulation of original data, ensuring FDA compliance ♦ Reduced data packets turnaround by 50% via the implementation of cross-training system and software training for vendors ♦ Transitioned 20+ studies to the CRO site, operating as the primary liaison in the business outsourcing unit ♦ Administered GLP compliant method development and validation for multiple key compounds (using HPLC) ♦ Established data authentication system and eliminated vendor manipulation of original data, ensuring FDA compliance ♦ Reduced data packets turnaround by 50% via the implementation of cross-training system and software training for vendors