Project Manager Quality Assurance

Location:

Bronx, NY

Posted:

August 09, 2025

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Resume:

Jalal H. Jafri

U.S. Citizen

* ******** ****, ****** ** 06820

***********@*****.***

203-***-****

Executive Summary

PMO Project Manager with over 14 years of experience in international Life Sciences, Medical Devices, Pharmaceutical and healthcare Project Management, and business analysis with all phases of software development Life Cycle (SDLC) using various methodologies including Waterfall and Agile. Managed various projects including high budgeted procurement, infrastructure, business processes, Quality Assurance, Regulatory Compliance, and LIMS during many mergers & acquisitions. Effective communication skills with varying levels of technical and non-technical individuals and cross functional groups with excellent people skills, to build consensus with senior management in different organizations.

Skills

Change Management

QMS/TrackWise

SDLC – Client facing

Medicaid plans / Medicare

Waterfall / Agile /Scrum

GMP / GLP / GDP / PHI

Procurement / RFPs

Health Home / CMAs

Vendor Management

LIMS / QMS / ISO 9001

SharePoint

MS Project / Smartsheet

Merger & Acquisition

Excel

PMO / PPM

Jira / Confluence / Scrum

HIPAA

ChatGPT

Maintain RAID for tasks

HealthRules Payor

Professional Experience

Project Manager (Consultant) 09/2023 – 6/2025

Amazon

Oversaw portfolio management, planning, development, and implementation of projects, change management, risk management, resource management, and vendor management—delivering IT and BPaaS solutions using industry standards and best practices for eCommerce marketing, sales and customer experience and advertising scaling through AI analytics.

Led multiple cross-functional project teams of 5 or more members.

Led multiple cross-functional project teams in defining requirements, creating business documents, planning testing and deployments, developing risk mitigation strategies, and executing post Go-live support and training—supporting both traditional and BPaaS-based service delivery models.

Facilitated cross-functional alignment by leveraging Jira, Teams for daily team coordination, and PowerPoint and Excel for biweekly executive status reporting, ensuring timely updates on milestones, risks, and decisions.

Supported Microsoft Dynamics (365D) ERP Procurement integration with Amazon Procurement Process, enabling scalable business operations framework and improving procurement process efficiency.

Conducted gap analysis by identifying relevant product documents and leveraging AI tools such as ChatGPT for research and process optimization—aligning with BPaaS transition objectives and identifying opportunities for automation and service standardization.

Managed the innovation pipeline from idea intake to implementation, connecting employees with resources and tracking KPIs to align initiatives with organizational strategy and digital transformation goals.

Project Manager (Contract) 10/2022 – 8/2023

Florida Blue Cross Blue Shield

Oversaw a portfolio of infrastructure and digital transformation projects, applying IT standards and healthcare payer best practices across change, risk, resource, and vendor management.

Led enterprise-wide innovation programs—including idea campaigns, internal challenges, and workshops—driving cross-functional engagement and embedding human-centered design and lean experimentation into business processes.

Managed IT infrastructure workstreams—such as cloud migration, networking, systems integration, or data center upgrades.

Managed AI and software project lifecycles, including scoping, planning, execution, and delivery of healthcare payer solutions.

Managed complex, cross-site integration projects during M&A initiatives, including health plans system consolidation.

Led multiple cross-functional project teams of 15 or more members including machine learning developers to build predictive models targeting duplicate billing, reducing costs, and ensuring correct claims payments through AI contract review.

Facilitated cross-functional alignment by leveraging Jira, Teams and Zoom for daily team coordination, and PowerPoint and Excel for biweekly executive status reporting, ensuring timely updates on milestones, risks, and decisions. Maintained RAID for project tasks.

Directed Agile and Waterfall projects for claims, provider portals, member enrollment, and Alternate Payment Models (APM, ACO, MCP), ensuring HIPAA, CMS, and contract compliance; tools included Jira, Confluence, MS Project, Smartsheet and ServiceNow.

Led AI-driven initiatives to enhance customer satisfaction through predictive analytics and automation; developed use cases leveraging ML for claims accuracy and provider payment validations.

Managed multiple cross-functional project teams of 15 or more members and vendor resources across the SDLC; developed project plans, budgets (up to $1.2M), and WBS; delivered 95% on-schedule and 98% on-budget outcomes per PMI standards.

Reported project status, metrics, risks, and roadmaps to executive stakeholders; supported governance and change control via steering committee reviews.

Facilitated end-user training, UAT, and post M&A support; kept documentation and reporting via Jira, Confluence, Smartsheet and MS Project.

Project Manager (Contract) 5/2022 – 8/2022

ThermoFisher Scientific

Directed cross-functional Agile teams (Scrum) using Jira and Confluence; ensured on-time delivery of AI/IT solutions while managing risks and resource planning.

Led multiple cross-functional project teams of 10 or more members.

Led development of AI and machine learning algorithms to extract clinical trial protocol elements from unstructured data, automating the RFQ process for CROs and significantly reducing response time and operational costs.

Oversaw integration of AI solutions into clinical operations workflows, enhancing protocol design, startup speed, and decision-making accuracy in decentralized trial environments.

Collaborated with data scientists, clinical SMEs, and IT teams to define and validate ML models using structured and unstructured clinical data, improving trial feasibility analysis and protocol consistency.

Provided end-to-end project leadership with a strong focus on regulatory compliance, partnering closely with legal, regulatory, and quality teams to ensure adherence to GxP, 21 CFR Part 11, HIPAA, and FDA guidelines; served as liaison between legal and technical teams to align contractual, data privacy, and compliance requirements across AI/ML and clinical systems.

Managed AI-focused project portfolios across life sciences, delivering software solutions that improved DCT (Decentralized Clinical Trial) processes and streamlined sponsor-CRO interactions.

Delivered DCT-focused platforms leveraging Medidata, Smartsheet and Microsoft Project, coordinating timelines, compliance efforts, and cross-functional collaboration.

Project Manager (Consultant) 12//2021 – 5/2022

Manhattanville Pharmacy, Inc

Managed the project portfolio by overseeing the planning, development, and execution of projects using IT solutions, standards, and best practices, including CMS compliance, HIPAA, and state reporting.

Led multiple cross-functional project teams of 5 or more members to develop requirements, testing and deployment planning, risk mitigation strategies, post go-live support and training, and project status reporting.

Supported Gap Analysis process to update the latest standards. Maintained RAID for project tasks.

Project Manager (Contract) 10/2020 – 11/2021

Takeda Pharmaceuticals

Oversaw portfolio management, planning, development, and implementation of infrastructure projects, change management, risk management, resource management, and vendor management, to deliver IT solutions using IT standards, and best practices for a major pharmaceutical firm.

Led multiple cross-functional project teams of 15 or more members, including architects, engineers, marketing, sales, and vendors to manage resources, conducted planning sessions, identified risks, and resolved issues.

Managed complex, cross-site integration projects during three M&A initiatives, including data centers consolidation and data migration from multiple sites into a unified data center.

Managed IT infrastructure workstreams—such as cloud migration, networking, systems integration, or data center upgrades.

Managed client-facing Life Sciences projects migrating legacy data/documents to Veeva Vault RIM, including submission management, product registration, HA correspondence, and archiving.

Established and kept project management standards to ensure delivery aligned with customer expectations on scope, timeline, cost, and performance.

Created and managed project schedules, budgets, scope, quality, and tracked risks and issues.

Led cross-functional teams using Agile and Waterfall methodologies to develop requirements and technical documentation; planned testing and deployment; implemented risk mitigation strategies; and managed post M&A support, end-user training, and project status reporting via Jira. Maintained RAID for project tasks.

Project Manager (Consultant) 03/2019 – 09/2020

DS Technologies, Stamford, CT

Client: Siemens.

Oversaw planning, development, and implementation of IT-enabled portfolio projects for medical device lifecycle management, ensuring alignment with FDA (21 CFR Part 820), EU MDR, ISO 13485, and CE/EMEA regulatory requirements.

Led multiple cross-functional project teams of 5 or more members, including architects, engineers, and vendors to manage resources, conducted planning sessions, identified risks, and resolved issues.

Led cross-functional project teams in gathering requirements, creating business and technical documentation, and executing system validation, testing, deployment planning, risk management, and post Go-Live support and training.

Conducted gap assessment ensuring regulatory compliance with evolving EU MDR and CE Marking requirements, supporting regulatory submissions and audits.

Facilitated risk mitigation strategies and implemented project reporting structures using tools such as MS Project, Smartsheet, Jira, and RAID logs to track performance, issues, and dependencies across the portfolio.

Ensured product and batch readiness for release by verifying alignment with quality system requirements (QSR) and ISO standards, including ISO 14971 (risk management) and ISO 13485 (quality for medical devices).

Collaborated with RA, QA, Legal, engineering, and manufacturing stakeholders to improve compliance traceability, enhance design control documentation.

Supported CAPA processes and continuous improvement initiatives by aligning system implementations with GxP and audit-readiness standards.

Project Manager (Contract) 11/2018 – 2/2019

Quest Diagnostics – Secaucus, New Jersey

Managed complex, cross-site integration projects during M&A initiatives, including QC Lab system consolidation and LIMS integration, ensuring minimal disruption to manufacturing and regulatory timelines. Delivered 93% on time execution with under 2% budget variance.

Managed IT infrastructure workstreams—such as cloud migration, networking, systems integration, or data center upgrades.

Planned and managed complex projects using AWS / SaaS Laboratory Information Systems (Labvantage), to streamline Lab operations, automate routine tasks, and to integrate medical lab disciplines into a single platform.

Managed scope, schedule, resources, budgets, ROI, risks, and deliverables ensuring GMP, GLP, GDP of FDS regulatory requirements for Life Sciences.

Collaborated with RA, QA, Legal, engineering, and manufacturing stakeholders to improve compliance traceability, enhance design control documentation.

Managed infrastructure projects for AWS / SaaS LIMS (Labvantage) including standardization of lab infrastructure, interfacing of instruments, security, data migration, and networks, and post M&A support and change management.

Defined and managed project scope, schedule, budget, risks, and dependencies for cloud-based LIMS implementation using MS Project and Smartsheet

Managed multiple Infrastructure / SaaS projects within Life Science firm – fully vendor managed, Cloud-based.

Assembled cross-functional teams to standardize lab equipment upgrades, managed LIMS vendor specifications for system compatibility.

Oversaw diverse projects including infrastructure, networks consolidation, security, and software validation (21 CFR Part 11), developing a vendor-managed support model and sprint management processes.

Identified resources and collaborated with stakeholders to mitigate risks and resolve issues.

Directed project teams in business case development, requirements gathering, documentation, testing, deployment planning, and training.

Project Manager (Contract) 5/2018 – 10/2018

Northwell Health, Manhasset, NY

Directed portfolio management and end-to-end project delivery for a major hospital, using Smartsheet and MS Project leveraging PMI, Waterfall and Agile methodologies to implement IT solutions aligned with industry standards and best practices. Oversaw change, risk, resource, and vendor management across multiple initiatives.

Managed scope, schedule, budget, risks, and issues for Population Health and Care Management programs, including health risk assessments, care coordination tools, and patient engagement platforms. Achieved 92% on-time delivery and 93% budget compliance across initiatives, aligning with PMI performance benchmarks.

Presented project health, KPIs, and milestones to executive leadership and stakeholders, supporting data-driven decisions and maintaining 90%+ stakeholder satisfaction.

Led project initiation and planning sessions with clinical, business, and technical leaders to define requirements, workflows, and processes across care management and quality reporting domains.

Built and led cross-functional teams; collaborated with enterprise architects, engineers, and clinical informatics staff to resolve technical challenges ensuring seamless delivery.

Handled vendor coordination and compliance tracking (e.g., CMS, HIPAA, PHI) during Facets implementations, ensuring contractual and regulatory obligations were met.

Reviewed and translated business requirements for clinical systems, including NY State Health Home MAPP App workflows (Membership, Eligibility, Enrollment, Tracking, Billing, Health Exchanges), ensuring alignment across QA, development, and business teams.

Prioritized requirements and negotiated deployment timelines with QA, developers, and product owners. Facilitated UAT, validated user stories, and ensured go-live readiness. Maintained scope stability in 90% of projects with minimal change-related impact and ensured effective risk mitigation across all phases of the project lifecycle.

Senior Business Analyst / Project Manager (Contract) 2/2017 – 4/2018

Aetna Health, New York, NY

Directed full SDLC execution including requirements gathering, functional documentation (BRDs/FRDs), cross-team coordination, QA and UAT, and deployment. Used Jira, Confluence, Smartsheet and MS Project for project tracking, issue management, and reporting.

Managed complex, cross-site integration projects during M&A initiatives, including health plans system consolidation.

Oversaw healthcare payer infrastructure and digital transformation projects, including Medicaid Facets benefits configuration, claims adjudication, member enrollment and customer experience. Ensured compliance with HIPAA, CMS, and payer-specific guidelines while delivering scalable IT solutions.

Facilitated cross-functional alignment by leveraging MS project, Smartsheet, Jira, Teams and Zoom for daily team coordination, and PowerPoint and Excel for biweekly executive status reporting, ensuring timely updates on milestones, risks, and decisions. Maintained RAID for project tasks.

Led AI/software project management for ActiveHealth’s CareEngine platform, directing cross-functional teams and machine learning developers to build predictive models that analyzed large-scale data from HIE, EMR, and EHR systems. Managed cross-functional team developing ML algorithms to detect clinical patterns and predict patient health outcomes, improving care management and initiative-taking clinical interventions.

Managed AI-driven use cases such as prediction of duplicate billing, automated contract reviews for accurate claims payments, and customer satisfaction optimization through AI-enabled insights and automation.

Delivered integrated solutions on platforms like HealthRules Payor, enabling real-time data exchange to reduce administrative costs and streamline claims processing and payment integrity.

Facilitated stakeholder engagement, change management, and steering committee alignment; managed project budgets (up to $1.2M), prioritized features, and maintained 95% schedule adherence and 98% budget compliance.

Defined AI-powered workflows for Care Management, Population Health, and Utilization Management web applications, improving clinical decision-making and health outcomes at scale.

Identified and analyzed data sources across payer and provider systems; collaborated with data scientists to design ML models that supported early detection of high-risk patients and improved clinical efficiency.

Senior Business Analyst (Consultant) 1/2017 – 2/2017

Cigna Health Insurance, Bloomfield, CT

Performed business, systems, and data analysis to identify data elements for membership, pricing, revenue, claims, and pharmacy from disparate and heterogeneous databases.

Data gathering sources included legacy systems, and Facets benefit configuration workflow, Claims adjudication, enrollment, workflow, and financial processing.

Reviewed source applications and systems to identify aggregate revenue and expense data elements to be extracted for loading and transforming into target Financial Data Warehouse.

Liaised between Business stakeholders, SMEs, Developers and facilitate approval of deliverables.

Project Manager (Permanent) 1/2015 – 1/2017

SYNERGY HOMECARE, Milford, CT

Managed projects to integrate and enhance applications including regulatory compliance; Applications included Hospice, health care scheduling, HR, CRM, Legal, Financial.

Responsible for standard Change Management procedure. Gathered, defined, and documented clear and complete business requirements and functional specifications. Used MS SQL, MS Access, MS SQL Server, and Excel to analyze data quality, data validation, and data compliance.

Project Manager (Consultant) 2/2013 – 1/2015

DS Technologies, Stamford, CT

Clients: Manhattanville Pharmacy, Mill-Run Tours

Managed projects to consolidate and transition financial accounting applications (ERP) to AWS - Cloud platform migration using MS Windows server and SQL Server.

Collaborated with State and Federal regulations, CMS, QA, Legal, engineering, and supply chain stakeholders to improve compliance traceability, enhance design control documentation. Contracted with third-party insurance.

Identified resources, built projects teams, initiated, and led planning meetings; led various cross-functional teams, architects, and engineers to resolve issues / challenges.

Managed financial applications integration with airline ticket ordering systems - Saved $1M.

Transitioned back office financial apps to Amazon cloud.

Managed conversion to IaaS platform, deploying; saved $1 million and reduced processing time by 30%.

Project Manager (Permanent) 3/2005 – 2/2013

Teva Pharmaceuticals USA – Pomona, NY

Managed complex, cross-site integration projects during three M&A initiatives, including QC Lab system consolidation and LIMS integration, ensuring minimal disruption to manufacturing and regulatory timelines. Delivered 95% on time execution with under 5% budget variance.

Led cross-functional teams in the successful implementation of TrackWise for CAPA management, improving audit readiness and reducing CAPA cycle time by 30% through process optimization and compliance alignment.

Converted from consultant to full-time PM at IVAX Pharmaceuticals, saving the plant over $1M by optimizing lab operations and consolidating project resources post-acquisition.

Collected, analyzed, and managed change control and impact assessments for LIMS workflows, ensuring alignment with quality, regulatory, and IT standards across global teams. Tools used: LIMS, Veeva Vault QMS, Smartsheet and MS Project, TrackWise, Excel-based validation matrices.

Oversaw batch release readiness, ensuring adherence to FDA 21 CFR Part 11, GMP, and GLP standards for documentation, quality assurance, and manufacturing compliance. Maintained 100% audit compliance.

Championed structured change management and communication planning, contributing to 90%+ stakeholder satisfaction and sustained operational efficiency during system migrations and validation efforts.

Led end-to-end procurement process for analytical lab equipment, consumables, and service contracts, including drafting RFPs, evaluating vendor bids, conducting technical/financial evaluations, and managing negotiations to ensure compliance with GMP and corporate procurement policies.

Monitored pharma industry trends in lab technologies and service models (e.g., equipment-as-a-service, sustainability standards), aligning procurement strategy with emerging innovation, lifecycle costs, and regulatory expectations to support long-term R&D and QC needs.

Collaborated cross-functionally with QC, R&D, QA, and Finance to forecast procurement needs, standardize lab consumables, and implement just-in-time inventory systems—resulting in a 15% reduction in lab supply costs and improved operational efficiency.

Project Manager (Consultant) 7/2003 – 3/2005

DS Technologies, Stamford, CT

Client: Alpharma Pharmaceuticals

Oversaw system validation and integration testing aligned with 21 CFR Part 11 standards.

Collaborated with quality, IT, and regulatory teams to enhance data integrity and compliance for inventory management systems across warehousing and manufacturing.

Championed improvements to testing SOPs and QC methods, reducing cycle times, and improving workflow efficiency by 20–25% through updated procedures, batch record accuracy, and streamlined data review processes.

Applied project management methodologies (SDLC), managed resources, timelines, and stakeholder engagement, and ensured successful delivery of validated QC lab systems.

Manager, Applications (Permanent) 7/2001 – 7/2003

Darien Public Schools, Darien, CT

Implemented and managed projects for educational applications, scope, budget, and schedule.

Gathered requirements, created business and functional requirements documents.

Manager, Applications (Permanent) 8/1999 – 6/2001

Primelearning.com – Stamford, CT

Oversaw all internal and external applications and infrastructure for E-Learning, CRM, and LMS applications.

Manager of Information Services (Permanent) 9/1996 – 6/1999

Stamford Board of Education – Stamford, CT

Successfully implemented $12 million IT Infrastructure projects and implemented networked labs within timeline, saving 35% of the budget.

Manager, Management Information Systems (Permanent) 10/1993 – 9/1996

Coler Memorial Hospital – New York, NY

Managed complex infrastructure projects during merger & acquisition of two hospitals/nursing homes.

Delivered a consolidated of data centers with unified software applications for all hospital clinical and business processes.

Education

BA: Managerial Economics, concentration in Computer Science, SUNY at Stony Brook, NY.

Candidate for PMP certification with University of Connecticut. A Plus, Network Plus & Security Plus.

Contact this candidate