Professional Project Manager -Program Manager

Maria C. Johnson-Ogrady

Professional Program Manager - Project Manager - Regulatory Affairs

******.******@******.** ~ Cell: XXX.XXX.5556 ~ Professional Summary

Results-Driven Project / Program Management Professional with 20+ years of successfully executing complex projects. Expertise spans Wireless Telecommunications Infrastructure, Digital Health, Real Estate Development / Repair, Software Development, Medical Devices, Pharmaceuticals, Utilities, Pesticides, and Government Projects. Proven track record in managing multiple $50M+ infrastructure upgrades, cloud migrations, and compliance initiatives within highly regulated environments. Exceptional in stakeholder management, regulatory compliance, and securing critical government approvals from agencies such as local, state and Federal Agencies (FDA, EPA, FCC, OSHA, NEPA, CEQA, and CPUC). Areas of Expertise

Project & Risk Management, Agile & Waterfall Development, Regulatory Compliance, Vendor Management, Cloud & Infrastructure Optimization, Budget Management, Scope, Cost & Schedule Management, Complex Government Procurement, RFP / RFQ / SOW / Supply Chain WBS, EVM, Cross-Functional Team Leadership, Mentoring Collaboration, Strong Decision-Making and Problem-Solving, Standard Operating Procedures (SOP), Design Controls, Process Improvement, Software as a Medical Device (SaMD), Quality Control Processes, Quality Assurance Standards, Lean Process Improvement, Change Management, and Change Control.

Professional Training

• PMI-Project Management Institute Professional Project Manager (PMP)

• Regulatory Affairs Compliance Certification (RAC)

• PMI-Project Management Institute Agile Certified Practitioner (ACP)

• Certified ScrumMaster (CSM) Scrum Alliance

• Six Sigma Green Belt Certified (SSGBC)

• Google- Contact Center AI/ML

• Google: Adoption Organizational Change and Culture Cloud Professional Experience

Advanced Project Management & Compliance Berkeley Executive Continued Training (Affiliated with UC Berkeley) Feb 2023 – Jan 2025

• Enhanced Project Management Expertise: Mastered advanced project management methodologies, including the development of comprehensive project plans, Risk Mitigation, and Traceability Matrices, Design Controls, GXP, to effectively manage timelines, deliverables, and milestones for high- impact projects across industries.

• Cross-Functional Collaboration and Leadership: Strengthened leadership and coordination skills by working with diverse teams—including R&D, Quality Assurance, Human Factors, and Regulatory Affairs—to ensure alignment with project objectives, adherence to compliance standards, and seamless execution.

• Design Controls and Development Process: Acquired expertise in implementing robust design controls (ISO 13485), encompassing a Waterfall Methodology, requirement, inputs, design and development outputs, verification, and validation processes. Leveraged iterative methods and continuous feedback loops to refine product functionality and ensure regulatory compliance.

• Risk Management and Mitigation: Developed in-depth knowledge of risk assessment and mitigation strategies to proactively address project uncertainties, ensuring successful delivery within scope and compliance frameworks.

• Agile and Hybrid Project Methodologies: Gained advanced skills in Agile, Scrum, and hybrid project management approaches, enhancing flexibility, collaboration, and adaptability in dynamic project environments.

• Process Improvement Initiatives: Applied process improvement techniques to optimize workflows, enhancing operational efficiency in labeling, packaging, and technical documentation processes to meet evolving industry and regulatory standards.

• Global Regulatory Frameworks and Compliance: Deepened understanding of global regulatory frameworks, including FDA 21 CFR Part 820, EU MDR, ISO 15223, and ISO 14971, ensuring comprehensive compliance across the product lifecycle in highly regulated industries.

• Technical Documentation and Compliance: Mastered the creation and maintenance of critical documentation, such as Design History Files (DHF) and Technical Files, to support regulatory submissions, audits, and post-market surveillance.

• Quality Systems and Change Management: Strengthened proficiency in enforcing quality system requirements, overseeing CAPA processes, and implementing effective change management strategies to maintain compliance and operational excellence. Global AI & Digital Health Innovator – Confidential Client, CA Oct 2021 – Nov 2022 Technical Project Manager

• Mid-Project SaMD Optimization: Stepped into a mid-project role, identifying critical gaps in software engineering practices. Streamlined ISO 13485 design controls and FDA 21 CFR Part 820 compliance processes, steering the project for regulatory submission & approval and market readiness.

• Comprehensive Software Project Management Risk Management and Mitigation: Led project management lifecycles using PMBOK Waterfall & Scrum frameworks, emphasizing design controls, requirements gathering, and iterative development to enhance software deliverability and compliance, human factors / usability, verification & validation, security controls, pen, vulnerability, and fuzz testing to identify risk and mitigate each to an acceptable level.

• Regulatory Compliance and Technical Oversight: Conducted an in-depth audit of the SaMD development process and standard operating procedures (SOP) to ensure alignment with IEC 62304 and EU MDR standard. Led the implementation of adjustments in risk management and software validation, securing seamless regulatory submission.

• Strategic Regulatory and Software Development Alignment: Collaborated on the global regulatory strategy for AI/ML-driven SaMD, ensuring that software development met rigorous market compliance, CE Marking, and labeling requirements.

• Market Expansion through Technical Leadership: Directed market expansion strategies into ASEAN, APAC, and EU regions, synchronizing technical project management with regulatory compliance to deliver software products that met global standards.

• Complex Regulatory Project Management: Administered regulatory projects across the EU and Australasia, focusing on software development activities such as remediation, rebranding, and localization. Managed technical reviews and contract renewals to ensure compliance with international standards.

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• Cross-Functional Technical Leadership: Fostered collaboration across Engineering, Quality, Product Development, Tech Writers, Product Managers and Regulatory teams, ensuring cohesive project delivery aligned with software development processes and regulatory requirements. Regulatory & Environmental Product Solutions Startup, Bay Area, CA Mar 2017 – Oct 2021 Senior Strategic Operations & Regulatory Compliance Leader

• Regulatory Leadership & Compliance: Led product lifecycle strategy for environmentally compliant solutions, ensuring adherence to U.S. & international regulatory frameworks (EPA, FIFRA, FDA, FCC). Managed compliance initiatives, product registration, and risk classification for U.S. & Chinese Partner-Agent.

• Operations & Vendor Management: Spearheaded contract negotiations, vendor oversight, and documentation control, implementing robust SOPs and quality compliance frameworks. Strengthened supply chain operations to align with global regulatory requirements.

• Product & Technology Strategy: Directed digital product transformation, including AI-powered eCommerce solutions, secure 2FA authentication, and payment gateway implementation.

• Strategic Compliance Initiatives: Established comprehensive packaging, labeling, and marketing compliance strategies aligning with U.S. regulatory bodies (EPA, FIFRA, FCC). Oversaw the creation of training programs, product documentation, and educational resources.

• Regulatory Framework Expertise: Specialized in EPA pesticide regulation compliance, aligning corporate processes with 40 CFR part 158, FIFRA Pesticide Registration Manual, and CFR 40 Parts 150–189. Top 5 Global Consulting Firm, Bay Area, CA Dec 2015 – Feb 2017 Enterprise Program Manager

• Strategic Operational Analysis for Company Processes Such as Utilities and Telecom: Spearheaded full evaluations of software tools, processes, and procedures across the enterprise. Focused on diagnosing inefficiencies and formulating a Lean strategy to drive enhancements and excellence.

• Lean Process Implementation: Led Value Stream Mapping initiatives to meticulously pinpoint optimization opportunities, successfully implementing targeted improvements that significantly enhanced organizational efficiency and productivity.

• Strategic Business Analysis: Identified critical business gaps and growth opportunities, facilitated data-driven meetings, and conducted analyses to pinpoint inefficiencies and capture key process improvement events, enhancing overall business strategy and operational efficiency. Executive Leadership and Implementation: Developed and presented comprehensive roadmaps and key performance indicators (KPIs) to the executive steering committee, establishing effective feedback loops to guide the organization toward a desired future state and drive continuous improvement initiatives.

Systems & Technology – Government County Agency, California June 2014 – Nov 2015 Project Manager – BA-PMO

• Project Management and RFP Leadership: Led the development and execution of the County’s first enterprise-wide RFP for a new CMMS solution integrated with Oracle PeopleSoft ERP, encompassing multiple departments, including Accounts Receivable, Facilities, and IT. Oversaw all aspects of the RFP lifecycle, from drafting the Statement of Work (SOW) to vendor selection and contractual compliance.

• Requirements Gathering and Stakeholder Collaboration: Facilitated cross-departmental workshops to gather comprehensive functional, technical, and regulatory requirements. Partnered with IT and departmental leaders to define integration points and streamline workflows, ensuring seamless data transfer between legacy systems and the CMMS platform. Developed use cases, wireframes, and API specifications to address both operational needs and compliance mandates.

• Complex System Integration and Data Migration: Designed and implemented robust API integrations to enable real-time, accurate data exchange between the CMMS and Oracle PeopleSoft ERP. Managed end-to-end data migration, ensuring integrity, accuracy, and security of legacy system data during the transition.

• Risk and Data Security Management: Conducted detailed risk analyses to address potential vulnerabilities during the cloud migration process. Developed strategies to ensure data confidentiality, integrity, and availability while incorporating future-proofing measures into the SOW.

• Stakeholder Engagement and Change Management: Established transparent communication channels with stakeholders across departments, providing timely updates on the software transition process. Addressed concerns through ongoing dialogue, ensuring user buy-in and a smooth change management experience.

• Adoption Monitoring and Reporting: Built detailed RFP provisions to track adoption metrics and user engagement post-implementation. Designed a comprehensive training and support plan, including hands-on workshops, e-learning modules, and user manuals tailored to various end-user groups. Provided ongoing support via helpdesks, FAQs, and user forums to maximize adoption and minimize disruption. Fortune 50 Telecommunications Leader, CA-GA Apr 2010 – May 2014 IT Program Manager

• Managed multiple $50million-dollar site development, IP and Cloud migration, and upgrade projects to reduce cost, improve reliability and sustainability while facilitating growth and security of the network from New York to Nevada / California

• Contract Negotiations: Acquire Greenfield, brownfield, residential, commercial Real Estate rights through purchase, licensing, leasing, subleasing, right of way, easements, and subdivisions.

• Draft and negotiate contracts, RFPs, RFQs, lease terms and conditions with large REITs, Retail owners, State Agencies, Railroads, Municipalities, Water/ Utility Districts, Port and Transportation Authorities, Universities, BLM and other Federal /State real estate holders.

• Collaborated on viable site designs, reviewed As-Builts, Construction Drawings and Redlines and submitted applications for Zoning, Building Permits

/ Entitlements with local Municipalities and Government Agencies

• Earned Value Management (EVM): Applied EVM to monitor and control budget, project performance, forecasting of multi-million-dollar budgets.

• Compliance and Regulatory: secure all local, state and Federal Entitlements adhering to corporate requirements, local, state, federal regulations.

• Advanced Schedule and Cost Management: Developed accurate Budget, Schedule with Contingency Reserves, WBS. Developed and maintained detailed project schedules, monitored dependencies and removed impediments while using MS Project and applied Earned Value Management (EVM) to monitor project performance, achieving less than 2% variance on multi-million-dollar budgets.

• Quality Assurance and Network Validation: Directed comprehensive pre- and post-installation testing and validation of upgraded equipment, including performance benchmarking, stability checks, and security assessments. Ensured continuous monitoring post-cutover to quickly identify and resolve issues.

• Led environmental and permitting activities for Greenfield, brownfield, commercial, residential, battery backup, generator backup, redundancy and large-scale infrastructure projects, ensuring compliance with local, state, and federal regulations such as BAAQMD, CPUC, CEQA, FCC, NEPA.

• Managed detailed environmental impact assessments (EIA), including Phase I Environmental Site Assessments (ESA), managed the mitigation strategies, Abatement and Remediation plans to address environmental concerns, protecting critical habitats.

• Interface with- local municipalities, state and federal agencies and attend public hearings to obtain all approvals

• Prepared comprehensive permit applications for submission to regulatory agencies, ensuring all environmental and technical requirements were met.

• Managed cross-functional Teams; From various originations (General Contractors, Real Estate / Land Acquisitions Reps, Regulatory / Compliance, A&E, Biologist, RF & Civil Engineers, legal advisors, field technicians, Permitting/Zoning, Planners, etc.). Facilitated effective collaboration and communication among stakeholders, including regulatory bodies to drive project consensus and compliance.

• Monitored and controlled: project scope, financing providing in-depth analysis of costs, change requests; schedule, quality, environmental permits and ensuring compliance with regulatory frameworks. Fortune 100 Telecommunications & Network Expansion PMO Midwest Markets Feb 2006 - Mar 2010 Program & Infrastructure Deployment Manager

• Acquired real estate rights: Acquire Greenfield, brownfield, residential, commercial Real Estate rights through purchase, licensing, leasing, subleasing, right of way, easements, and subdivisions. Managed site development projects, ensuring compliance with environmental and zoning regulations. Negotiated contracts, lease terms and conditions with large REITs, Railroads, CalTrans, retail owners, state and Federal agencies to secure lease agreements and land use permits.

• Earned Value Management (EVM): Applied EVM to monitor and control budget, project performance, forecasting of multi-million-dollar budgets.

• Fiber and Electric Projects: Fiber to the Cell Site successfully managed site upgrades / Fiber Project in multiple states and markets, Cisco Siads, Switch upgrades leading to LTE 5G to ensure existing site stability, reliability and security.

• Collaborated on viable site designs, reviewed As-Builts, Construction Drawings and Redlines and submitted applications for Zoning, Building Permits

/ Entitlements with local Municipalities and Government Agencies

• Draft and negotiate contracts, RFPs, RFQs, lease terms and conditions with large REITs, Retail owners, State Agencies, Railroads, Municipalities, Water/ Utility Districts, Port and Transportation Authorities, Universities, BLM and other Federal /State real estate holders.

• Conducted stakeholder engagement - public consultation sessions, addressing concerns from local communities and regulatory agencies. Interfaced with local municipalities, state and federal agencies, and attended public hearings to obtain all necessary approvals.

• Managed the preparation and submission of zoning and permitting applications for telecommunications infrastructure projects, ensuring compliance with local, state, and federal regulations.

• Conducted technical site evaluations and environmental assessments, ensuring all proposed sites met regulatory and environmental standards.

• Developed and maintained relationships with regulatory agencies such as the Public Utilities Commission (CPUC), and local municipalities to facilitate the permitting process.

• Implemented risk management strategies - to address potential environmental and regulatory challenges, ensuring project timelines and budgets were maintained

• Managed environmental processes: Including the development of environmental impact assessments (EIA), Phase I and Phase II Environmental Site Assessments (ESA), remediation, and abatement mitigation plans. National Wireless Infrastructure & Regulatory Operations California Jan 2000 – Dec 2005 Regional Infrastructure Development & Compliance Strategy Manager

• Retained to oversee critical new builds and upgrades: new site build development, DAS solutions, small cell projects, battery backup and generator backup. With a focus on Greenfields, Brownfields, commercial, residential, stadiums, hospitals, schools, convention centers, rapid transportation authorities and special events.

• Draft and negotiate contracts, lease terms and conditions with large REITs, Retail owners, State Agencies, Railroads, Municipalities, Water/ Utility Districts, Port and Transportation Authorities, Universities, BLM and other Federal /State real estate holders.

• Led Cross-functional Teams: Managed and collaborated with cross-functional Teams from various originations (General Contractors, Real Estate, Regulatory / Compliance, A&E, RF & Civil Engineers, Biologist, field technicians, permitting, etc.)

• Earned Value Management (EVM): Applied EVM to monitor and control budget, project performance, forecasting of multi-million-dollar budgets.

• Developed & Reviewed Site Plans: Reviewed As-Builts, Construction Design Drawings and Redlines. Submitted applications for Zoning Permitting Entitlements with local Municipalities and Government Agencies.

• Interfaced with local municipalities, state and federal agencies, and attended public hearings to obtain all necessary approvals.

• Collaborated with regulatory agencies such as USFWS, BLM, and local municipalities to secure necessary environmental and zoning permits through rigorous adherence to Section 106, SHPO, NEPA, TCNS, and other regulatory frameworks.

• Implemented environmental permitting strategies, including ESA Phase I and II environmental impact assessments Abatement and Remediation plans, to secure all local, state and Federal Entitlements adhering to corporate requirements, local, state, federal regulations: Permitting, mitigation plans protecting critical habitats

• Conducted technical due diligence reviews of environmental permits for project financing activities. Education

• California State University, Area of Study-Sociology

• Chapman Law School Anaheim, CA

Technical Skills

• Microsoft Project Microsoft Office Suite (Word, Excel, PowerPoint, Access, Outlook, Visio)

• Jira Workfront Adobe Elements / Photoshop

• SAP Ariba Oracle Agile PLM Oracle PeopleSoft Enterprise Resource Planning (ERP)

• Google Cloud: Contact Center AI/ML Google Docs Home Remodel and Repairs

• SharePoint / Teams Salesforce Power BI

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