Urmi Dixit-Parkar Email & Phone Number

Blue Bell, Pennsylvania, United States

• Led efforts to ensure software systems used in clinical trials were compliant with regulations and met product quality expectations. • Guided software engineering teams in implementing agile SDLC processes to ensure timely release of high-quality SaaS products.• Led integration of technology acquisitions, developed integration strategy, obtained stakeholder approval and executed plans ensuring alignment of quality resources and processes while maintaining business continuity.• Evaluated current processes, assessed risks and proposed risk mitigation strategies. • Managed efforts for standardization and advancement of validation methodologies in support of digital health technologies and other GxP systems used in clinical trials (traditional and decentralized).• Developed a robust quality framework to guide the company in conducting compliant decentralized clinical trials.• Provided guidance to operational and technology groups, ensuring the business understood applicability of associated published regulatory guidance regarding 21CFR Part 11, EU GMP Annex 11, EMA and GCP.• Oversaw the development and implementation of a robust data integrity framework • Developed and implemented computerized system auditing strategies, hosted sponsor audits, supported inspections and conducted vendor audits.• Developed and fostered a positive relationship with internal business units to ensure a common understanding, approach and appreciation for computerized system validation and compliance.• Authored and reviewed corporate policies, standard operating procedures, work instructions and guidance documents that influenced the direction of quality and compliance initiatives.• Established a robust quality metrics framework for reporting KPIs to senior management and made recommendations for driving cross-functional improvements across the organization. • Hired and mentored staff on software quality engineering, auditing and compliance practices.

San Ramon, California, United States

• Led a group of software quality assurance engineers, compliance specialists, product support specialists, product trainers and technical writers responsible for the successful delivery and maintenance of Prism (Electronic Data Capture system used in clinical trials).• Designed and implemented test frameworks to ensure software products were of the highest quality.• Defined and implemented IQ, OQ and PQ procedures.• Collaborated with internal stakeholders in implementing disaster recovery and business continuity procedures.• Developed and implemented a robust Quality Management System. • Drove the development, training and adoption of policies and standard operating procedures across the organization.• Defined and implemented corporate practices and standards to ensure compliance with applicable regulations (FDA (21 CFR Part 11), GCP, Safe Harbor). • Developed and implemented CAPA procedures to ensure quality issues were addressed appropriately. • Led the corporate audit program comprising of sponsor, internal and vendor audits. • Implemented U.S.-EU and U.S.-Swiss Safe Harbor certification.• Successfully transitioned from paper-based audits to electronic system-based audits, which resulted in improving efficiency in running audits and in cutting costs associated with storage of paper records.• Ensured product support and training programs were effective in supporting client needs.

San Ramon, California, United States

• Built a QA team from the ground up. Trained and mentored software QA engineers for validating Prism, which is an Electronic Data Capture system designed for managing clinical trial data.• Implemented quality engineering procedures and frameworks to support agile methodologies.

Berkeley, California, United States

Joined as a Sr. SW QA Engineer and after multiple promotions was working in the position of a Senior Manager responsible for leading a global team consisting of software QA engineers, project managers and technical writers. • Defined and implemented SDLC procedures, QA processes and test automation frameworks for ensuring timely release of high quality bio-informatics products.• Defined and implemented project management, technical writing and QA team participation in all stages of the software development life cycle. • Worked with senior management in defining budget, scope, schedule and resources for projects.• Hired and trained staff as needed.

Emeryville, California, United States

• Led a team of software QA engineers in testing a data collection, data processing and reporting system. • Participated in developing testing policies, standards and procedures.• Developed and executed comprehensive test plans for Corporate Data Reports.• Performed extensive functionality testing of tools that were used by editors to create knowledge bases for Ask Jeeves corporate clients.

Master Of Science - Ms, Chemistry

Bachelor Of Science - Bs, Chemistry