•Managed and directed ongoing compliance and Quality Assurance activities for key Projects to ensure Preclinical, Clinical, safety, and PV activities were performed in compliance with FDA, EMA, and other applicable regulatory requirements.•Provided leadership and guidance to mature EQRx Quality infrastructure, including QMS supporting R&D Quality operations.•Managed and conducted qualification and routine audits of key vendors and CRO’s as part of the Vendor qualification and management program.•Fostered effective and constructive communication with Clinical Operations, Medical Writing, Biostatistics, Data Management, Pharmacovigilance and provided quality assurance inputs to changes to policies and working practices.•Reviewed scientific data and supporting documentation for IND and NDA filings and participated in meetings between Quality and technical departments ensuring an interdepartmental team approach in the development of responses to the different queries from the different regulatory agencies.•Led and managed activities to support Inspection Readiness for upcoming MHRA and EMA inspections.

• Oversee and manage all aspects of the company Quality Management system.• Created a part 11 compliant electronic Quality Management System for the management of all quality documents, quality events, change control, deviations, CAPA’s, quality metrics, quality audits and supplier quality management.• Conducted, facilitated, and managed all internal self-inspections of On Target Laboratories and all external audits of critical vendors for both the CMC and the Clinical Operations department.• Conducted quarterly quality metrics reviews with the senior management, providing these reviews to the board of directors every 6 months.• Facilitated and managed a Mock BIMO inspection for the current Phase III program by engaging an ex -FDA Inspector to conduct an independent audit as part of the Inspection readiness initiative.• Successfully managed FDA site inspections of two clinical sites of the current Phase III program with no 483’s.• Facilitated and provided quality review and approvals for all company investigations, deviations, and CAPAs.• Provided quality leadership to the CMC department including review and approval of Contract Manufacturing Organizations (CMOs) technical transfer documents, protocols and reports, batch records, batch release documentation, deviations, investigations including out of specifications (OOS) investigations, and change controls.• Provided quality oversight to the Clinical Operations department including vendor selection and qualification, audits of vendors, preparation and facilitation for regulatory agency inspections, and communication of best practices and lessons learned from inspections.• Managed all Quality Assurance responsibilities pertaining to the maintenance of the supply chain temperature excursions and product quality complaints.• Reviewed and provided inputs on the regulatory submissions for the IND, NDA, and sNDA packages and the RFI’s.

•Successfully performed the Technical Transfer of the Korsuva Injection at the 3 CMO sites Internationally (US, Italy, and Germany).•Successfully completed the manufacture of the 9 PPQ validation batches at the 3 CMO’s to support Cara’s NDA submission for Korsuva Injection in December 2020.•Led the Inspection readiness initiative of Cara and successfully completed the conduct of 2 Mock Inspections between June 2020 and February 2021.•Successfully hosted the FDA Inspection of Cara in March 2021 with no observations or 483’s as the QA Lead for CMC, Safety and PV, Biostatistics and Data Management and Regulatory Affairs Departments.•Contributed to the Cara Quality Audit Program based on compliance risks identified by performing Gap analysis and mitigating the risks.•Performed a total of eleven GLP/ GMP audits of CMO’s, Bio analytical Laboratories as well as CRO’s and Suppliers as the Lead Auditor within the last 10 months.•Performed Gap analysis on the Quality Assurance and CMC areas and authored over 10 SOPs within a span of 4 months.•Provided support and inputs in authoring over 24 SOPs for the Safety and PV, Clinical Operations, Medical Affairs, Medical Monitoring and Regulatory Affairs group.•Consulted, assessed, and approved investigations, root cause analysis and CAPA’s.•Provided data for reporting quality risk metrics to Senior Management on a quarterly basis.

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

♦ 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.

♦ 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

♦ 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