-Facilitates the Development, implementation and maintenance of QA systems and SOPs for GCP activities.-Supports daily and end-to-end compliance aspects of the portfolio of GCP focused vendors -Works with internal GCP customers and develop and execute strategic audit plans.-Coordinates, develops, maintains and/or provides GCP training.-Maintains relevant knowledge of both local and international auditing and appropriate GCP requirements and developments as they impact Boston Biomedical’s SOPs and compliance with GCP, and communicate these to QA management, as applicable.-Provides extensive experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including applicable GCP auditing. -Plans, prepares, performs and reviews audits according to the audit schedule.-Trending audit findings.-Reviews clinical deviations and clinical deviation trends.-Ensures the establishment of an appropriate audit responses and timescale of corrective actions in cooperation with vendors and stakeholders.-Monitors vendor corrective and preventive actions.-Supports the Internal Audit Program.-Participates in Inspection Readiness activities including FDA "Mock" inspections, training and support activities.

• Key focus on Regulatory Process and Compliance matters related to Investigational New Drug Applications, Clinical Development and Clinical trial related submissions (1572, IND updates, IND Annual Reports, Safety Updates, etc).• Provides/coordinates GCP training and act as SME in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, or other relevant area, including applicable GCP auditing• Managing, analyzing and reporting on the compliance measures, trending audit findings, clinical deviations and trends and key performance indicators for US-focused regulatory processes and activities.• Monitors vendor corrective and preventive actions and supports the audit program.• Supports in the inspection readiness activities, Regulatory and third-party inspections.• Prepare and review of appropriate audit response in a timescale of CAPA with vendors and stakeholders. • Maintains relevant knowledge of both local and international auditing and appropriate GCP requirements and developments• Provide QA review to regulatory submission documents.

• Developed, implemented and maintained QA GCP systems and SOPs.• Developed risk based and quality audit plan for internal and external GCP audits.• Prepared risk and gaps analyses report and take appropriate CAPA in a timely fashion to avoid deficiencies.• Identifies, escalates critical quality issues to upper management, such as vendor assessment, internal and external audit with recommendation of required actions.• Conducted, monitored and follow up on internal audits and external audits including the 21 CFR part 11.• Plans, monitor and coordinated regulatory affairs activities to ensure compliance with current requirements of all local, State and federal agencies.• Managed current regulatory licenses/permits status with the required Agencies.• Provided Good Clinical Practice (GCP) training programs for employees.• Worked with vendors to ensure quality standards are met and resolve issues promptly and effectively.• Coordinated as inspection host for various audits that includes pharma audits, College of American Pathologist (CAP) audits, State DOH audits, FDA mock audits, and ISO audits).• Reviewed, assessed and wrote required processes and procedures (SOPs) and enforced the compliance.• Engage directly with representatives of regulatory agencies as required.• Managed and provided oversight of timely reporting of epidemiology to state health departments.

• Scheduled and developed audit plan and work with contracted auditors for clinical sites in US & India.• Provided oversight of CQA auditors to develop specific audit plans, review and assess internal and external audit reports to ensure that suggested CAPA are adequate to ensure compliance with SOPs and Regulations.• Conducted GCP site audits using BIMO guidelines, clinical study report audits, Sponsor TMF audits, vendor audits, GLP audits and participated FDA inspection preparedness audits.• Coordinated the FDA audit at the sponsor’s site that lasted for two weeks.• Collaborate with appropriate cross functions such as Clinical Operations, QA/RA, Data Management and Safety to follow up to clinical site audits (audit reports) to ensure resolutions of audit findings in accordance with established standards.• Conducted remote vendor audit such as Central lab, CRO services, and other external resources as needed.• Provided follow up corrective actions with proposed and contracted vendor services.• Facilitated and organized the compilation of application (IND, NDA) to FDA in support of research products.• Managed & provided oversight for preparation and timely submissions of annual IND report, Serious Adverse Event (SAE) program to the FDA.• Facilitated and organized the Trial Master File (TMF) essential documents for the conduct of all clinical trials at the sponsor’s site and managed regulatory file for 13 protocols • Coordinated training/continuing such as GCP training and other regulatory affairs activities.• Oversight of GCP vendors• Reviewed, assessed and wrote required process and procedures (SOPs)

• Educated Clinical trial patient regarding the study protocol and informed consent.• Managed and completed clinical trial study that includes study of protocols, completion of FDA 1572 forms, IRB submission materials along with financial disclosure forms, CRFs and eCRF and various other site questionnaire forms.• Coordinated the clinical research trials conducted at the investigative site in accordance with sponsor study protocol, SOPs, GCP, ICH Guideline and adherence to FDA regulation.• Coordinated the CRA monitoring activity at the clinical site.• Maintenance of trial Master File (TMF) and accountability of drug reconciliation.• Participated in the investigator’s meeting.• Reviewed, assessed and wrote required process and procedures (SOPs)• Served as liaison support for various job functions as needed.