Arvita Tripati, Mba Email & Phone Number

San Francisco, Ca, Us

Doylestown, Pa, Us

--Led AI and digital transformation strategy across commercial, R&D, and client services, achieving 65X ROI on AI initiatives.--Led the strategic delivery of an MVP, securing a top 5 biopharma customer and driving long-term growth through digital innovation, positioning the company for sustained market success and transformation.--Defined and executed a strategic framework for a B2B SaaS clinical trials supply chain startup, driving innovation and operational scalability.--Developed data and governance strategies to automate complex clinical trial protocols, improving efficiency and compliance.--Served as interim Head of Engineering, driving coding standards, architecture, and scalable digital solutions.--Oversaw cross-functional teams of 50+ across Product, Engineering, DevOps, IT, and Compliance, fostering a high-performance culture and operational excellence.--Transformed Professional Services and Customer Support organizations through operational optimization, KPI development, and strategic alignment with digital goals.--Led five international contracting teams, driving execution and alignment across Armenia, Pakistan, India, and Brazil.--Conducted critical "build vs buy" assessments and technical due diligence, enhancing investor confidence and driving customer acquisition.--Created board presentations and sales collateral to communicate digital transformation initiatives and compliance strategies, driving stakeholder engagement.Background: B2B SaaS w with AI; eClinical Supply Chain; highly configurable software for clinical trial supply chain. As employee #1 joined to launch product vision, strategy, and engineering for the design and architecture of the application and infrastructure. Built the company infrastructure and team, executed product design, helped secure customers, and established compliance policies for quality, privacy, and security.

New York, New York, Us

A VC studio portfolio companies that powers innovation in healthcare by developing technologies, tools, and insights that lower the barriers to change across the industry.

--Drove strategic pivot from STD to COVID testing, generating 250% growth in product revenue. --Worked directly with the CEO to define product vision, strategy, OKR framework, and roadmap.--Worked with 40+ internal & external stakeholders to pilot & launch products--Partnered with Data Science to set standards for responsible AI, accelerating product deployment by 30% and improving model accuracy by 15% to enhance user experience and reliability. --Established governance frameworks reducing review cycles 27% increasing release cadence. --Standardized engineering and manufacturing processes, achieving a 35% faster delivery speed and 20% cost reduction to scale production capacity in line with product demand. --Scaled the company from 8 to 130 with 90% retention, aligning talent strategy with growth objectives and preparing for Series B funding.--Led and managed team of 10, navigating through a RIF with 100% retention of high performers. --Partnerships included: NIH RADx, Sanofi, eMedA Series B, B2B hardware, software, & AI company that provides in vitro diagnostics; supported by Y Combinator and Khosla Ventures; won the National Institutes of Health RADx challenge. Promoted to right-size the title to better align with the role after supporting growth from Seed to Series B, and from 8 to 130 employees.

Wakefield, Massachusetts, Us

Wakefield, Massachusetts, Us

--Launched internal product scaling compliance automation by 32%, leading to 18% faster audit cycles, a 57% ROI, and 4x team growth with 0% turnover. --Led a 20 person global product compliance team--Launched 2 product updates across 3,000+ B2B applications. --Led COGS optimization, achieving a 20% cost reduction by setting OKRs that aligned product and departmental goals. --Elevated board engagement with product-driven risk presentations, enabling faster decisions on compliance and security that impact product market readiness. --Defined a data strategy with IT and R&D, reducing data errors by 30% and accelerating delivery timelines by 25% to meet product milestones.--Clients included: Moderna, Bristol-Myers Squibb, AbbVie, Takeda, Roche/Genentech, GileadA 500-employee B2B SaaS, AI, and eClinical Supply Chain product and a subsidiary of a public, Fortune 500 company. Promoted to right-size the title; reported to the CEO of endpoint and dotted line to the CISO and CPO of Labcorp, a 65,000-employee business.

San Francisco, California, Us

San Francisco, California, Us

--Aligned OKRs with product goals, boosting release cadence by 40%, enabling a two-month early launch, and driving $81M in additional revenue for Gilead. --Partnered with sales by creating targeted white papers, raising client engagement by 25%. --Presented comprehensive product and corporate risk management strategies to the Board, proactively addressing critical quality, regulatory, privacy, and security risks. --Scaled the company from 3 to 70 employees, fostering an Agile quality-driven culture. --Led test engineering and SaaS validation efforts, reducing security vulnerabilities by 50%.--Clients included: Novartis, Gilead, Johnson & Johnson, Red Cross of AmericaA Series B, B2B SaaS, cell therapy supply chain company funded by GE Ventures, DFJ, Canaan, and Threshold. Promoted to take over additional responsibilities as the company grew rapidly; led privacy and security.

Mountain View, Ca, Us

--Delivered 8x revenue growth along with increasing margin by over 2x. --Expanded EU market reach and integrated with Apple Watch, increasing accessibility by 30%. --Scaled production 27X by relocating manufacturing to China, maintaining quality and reducing supply chain costs by 15%. --Defined responsible AI model standards with Data Science to streamline FDA submissions, reducing preparation time by 22% for faster product approval. --Defined and analyzed product metrics to identify improvement opportunities, cutting customer service expenses by 7% and improving response times by 15%. --Defended against FDA inspection post-recall, restoring regulatory trust and avoiding penalties. --Established privacy and security functions, reducing data breach risk by 40%.--Partnerships included: Omron, GE Healthcare, LifewatchA B2B & B2C cardiac monitoring device company with hardware and software led by AI with growth from Series B to Series C. Backed by Khosla Ventures and WP Global.

Madison, Wi, Us

A public B2B 1100-person medical device company focused on capital radiation oncology and radiotherapy equipment, with hardware and software using AI for surgical robotics. Hired to lead the audit function.- Planned, coordinated, and executed regulatory compliance audit program for the global organization, including locations in Japan, China, Hong Kong, Switzerland, and the US; developed and implemented the structure for the global quality system and global quality policies and procedures. - Worked with global R&D, manufacturing, service, and commercial organizations to audit sites for compliance; addressed audit non-conformities; and developed inspection response and training.- Established the regulatory intelligence process.- Defended against an FDA inspection to support the queries and ensured no findings.

San Ramon, California, Us

A public Fortune 1000 B2B and B2C medical device subsidiary of The Cooper Companies focused on developing & commercializing soft contact lenses. Planned and coordinated regulatory compliance audits as part of a system gap analysis; developed structure for global quality system and global quality policies and procedures and implemented the structures. Worked with global logistics and commercial organizations at various sites to develop instructions for compliance with global policies. Served as Management Representative for OUS, OEU, and O-Japan sites, HSA, and registrar audits. - Developed qualification policies, procedures, and requirements agreement template for selection & evaluation of contract design, manufacture, logistics, and distributors; audited vendors and oversaw remediation plans.- Developed an internal Global Complaints Capture system to ensure the consistent and timely reporting of complaints; collaborated with IT to integrate salesforce CRM and Oracle EQMS, linked complaints reporting tools.- Worked with Global QA and Commercial Operations to develop a recall handbook and templates.- Participated in the development of a Warning Letter response for our Puerto Rico manufacturing facility.

Milpitas, Ca, Us

Privately owned medical device contract manufacturer focused on radio frequency capital equipment and disposables.- Quality Systems Development: Reviewed applicable standards, developed strategy, negotiated implementation, and provided training. Completely revamped and designated process owner for CAPA, Process Validation, Sterilization Controls, Risk Management, and Design Controls procedures. - Reviewed and approved product specifications, hardware/software requirements, software architecture, and software design documents. Assisted in the development of verification and process validation protocols. - Created, submitted, and defended technical files; created and revised sections of 510k submissions.- Led internal audit program, including selection, qualification, and supervision of audit team and reported results to management. Responded to audit findings.

A small, privately owned start-up medical device company focused on implantable neurostimulation systems.- Collaborated with R&D to develop system, product, and mechanical verification; process qualification; and system validation plans. - Led the team and the development of risk documentation. - Worked with contract manufacturers and component suppliers to improve performance and produce auditable documentation including device history records and manufacturing instructions.

Us

Us

Us

Chief Data And Ai Officer Certificate Program, Artificial Intelligence

Certificate, Ai Product Management & Leadership

Women On Boards

Education record

Gdpr Ready, Eu Data Privacy And Privacy Program Management

Master Of Business Administration (M.B.A.), Marketing

Certificate, Regulatory Affairs

Bachelor Of Arts - Ba, European Intellectual History