Program Management Project Manager

Connie O’Grady PMP, PMI-ACP, CSM, RAC

Program / Project Manager / Regulatory Affairs

Email: **************@*****.*** Cell: 925-***-**** Oakland, CA 94611 Professional Summary

Results-Driven Project / Program Management Professional: With 14+ years of successfully executing diverse, complex projects, I bring a proven track record in driving profitable growth through innovation and strategic leadership. My expertise spans various industries including Medical Device, Wireless Telecommunications, Real Estate Development, Land Acquisition, Permitting, Construction, EPA, Infrastructure / Network Upgrades, Software Development, Utility, Pesticides and Government Project. I excel in navigating heavily regulated landscapes. Notable achievements include successfully managing multiple

$50+M infrastructure upgrades, data center cloud migrations and analog to IP migration initiative at AT&T due to mergers & acquisitions and long-term evolution (LTE) 5G, resulting in significant cost savings and heightened infrastructure reliability. Exceptional in stakeholder management and communication. Skilled in obtaining critical government approvals and permits from local, state and federal agencies such as: EPA, FIFRA, FDA, ADA, OSHPD, OSHA FAA, FCC, (NEPA, TCNS, SHPO) CEQA, BAAQMD, DSA, CPUC, CEC, CalTrans, USFWS, BLM and local municipalities. I am committed to driving success and sustainability in highly regulated environments making me a prime candidate for leading roles in Regulatory Affairs and Project

/ Program Management.

Certifications

• UC Berkeley Regulatory Affairs Certification (RAC)

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

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

• Certified ScrumMaster (CSM) Scrum Alliance

• Six Sigma Green Belt Certified (SSGBC)

• Google Cloud: CCAI Contact Center AI / ML

• Google Cloud: Organizational Change & Culture for Adopting Google Cloud

• Import / Export Certification World Trade Center, Bay Area Areas of Expertise

• Project Management Methodologies: Cross-Functional Teams, Project Planning, Resource and Vendor Management, Cost, Scope, Schedule Control, Risk Management, decision-making, Problem Solving Skills, Quality Management, Stakeholder Communication, V & V, Roadmap, Conflict Resolution, RFP / RFQ / SOW / Supply Chain, Mergers & Acquisition Management

• Agile Methodologies: Scrum, Agile Coach, Agile Project Management, Waterfall Development, Lean Thinking, Continuous Improvement, Mentoring, Development & Training, Standup Meetings, Retrospectives

• Quality Assurance/Control: QMS, Quality Control Processes, Quality Assurance Standards, Lean Process Improvement, Change Control, SOP Development, Risk Mitigation, Design Controls, Testing, Inspection, Verification & Validation

• Advanced Financial Oversight: Optimize financial oversight, maximize value, and utilize Earned Value Management

(EVM): Performance Baselines, Project Health Assessment, forecasting, Schedule and Cost Baseline, trends, variances and ROI.

• Regulatory Affairs: FDA, MDD, MDR, IVDR, TGA, HSA, EMEA, APAC/ ASEAN MDD, LATAM Regulations, FCC Regulations, ADA Compliance, HIPAA, OSHPD Regulations, EPA / FIFRA Regulations, CE Marking, GTIN/ UDI-DI, Harmonized Standards, ICH Guidelines, IMDRF, Package /Labeling, Art, IFU, Advertisement, Promotions, AE Reporting. Medical Device Development, 510k, IDE, PMA & MDR, eCTD Submission, CE Marking, Technical File, DHF, DMR, DHF & UDI Management, Harmonized Standards, QMS, ISO 13485, Risk Management ISO 14971, PMS, PMCF

• Software Development & Implementation: SDLC which meets regulations, SaMD, SiMD FDA Design Controls 820.30, MDSW Regulations, Digital Health Technology, Precision Medicine, Wellness Software Development Life Cycle, IEC 62304, Quality ISO 13485, ISO 14971, HIPAA IEC 81001-5-1 security, Usability IEC 62366-1, Software LOC Classification aka Basic Documentation or Enhanced Documentation

• Infrastructure Upgrade and Cloud Migration: Infrastructure Enhancement, Cloud Migration Strategies, Cost Reduction Initiatives, Network Reliability, Cybersecurity, Pen Testing & Vulnerability Testing Professional Experience

Medtronic Diabetes - Northridge California Feb 2024 – May 2024 (Backfill) Project Manager Technical Communications

• Project Management Excellence: Developed and managed Project Plans, Schedule, Monitored and Controlled Project, Risk Management, and Traceability Matrices, tracking deliverables and maintaining strict adherence to timelines and regulatory milestones.

• Regulatory Strategy Optimization: Stepped in mid-project to streamline regulatory strategy for Product Life Cycle Technical Communications and labeling, ensuring compliance with FDA 21 CFR Part 820, EU MDR, and ISO 15223, facilitating timely global product launches.

• Cross-Functional Leadership: Integrated with R&D, Quality, Human Factors / Usability and Regulatory teams to drive the creation and review of all Technical Communication (CE Marking, GTIN, IFUs, Media), ensuring adherence to design controls and regulatory standards.

• Quality Assurance & Compliance: Ensured meticulous maintenance of DHF documentation, Post Market Surveillance, CAPAs, Design Controls reinforcing compliance with FDA and MDR technical file requirements throughout the product lifecycle.

• Risk Mitigation: Led risk assessments and implemented mitigation strategies to address potential project and regulatory risks, ensuring alignment with company objectives.

• Stakeholder Communication: Managed stakeholder communications, providing timely updates on project status and fostering a collaborative, compliant project environment.

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• Continuous Improvement: Drove continuous improvement in labeling and packaging processes, enhancing operational efficiency and ensuring ongoing regulatory compliance.

• Cybersecurity and Data Integrity: Maintained and enforced robust cybersecurity integration into all Technical Files, including two-factor authentication and Pen Testing & Vulnerability Testing Plans & Summaries, ensuring the protection of patient data and device functionality. Continued adherence to industry best practices and regulatory requirements for digital health technologies. Personal Growth Regulatory Affairs Certification: UC Berkeley California Jan 2023 – Dec 2023

• Mastered US regulations and international guidelines to ensure compliance across diverse industries, safeguarding product integrity and market readiness.

• Acquired expertise in managing regulatory documentation and submissions, ensuring alignment with global regulatory requirements for clinical trials and product launches.

• Developed cross-functional expertise in quality and compliance standards, supporting product development, manufacturing, and supply chain management with a focus on regulatory strategies and operational excellence.

• Cultivated knowledge in regulatory risk and cybersecurity assessment and mitigation, ensuring proactive management of compliance issues and regulatory challenges.

Google Health, San Francisco, CA Nov 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 back on track 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 to ensure alignment with IEC 62304 and EU MDR standards. 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.

• 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.

Travel BugBan Plugins LLC, Oakland, CA Mar 2017 – Oct 2021 Partner Director of Regulatory Affairs Program Manager

• Regulatory Leadership: Directed full product lifecycle development of environmentally friendly products, ensuring compliance with EPA, FIFRA, FDA, and FCC regulations. Spearheaded risk classification and managed regulatory affairs for US and China markets, overseeing all facets of product registration and compliance.

• Operational Oversight: Conducted rigorous contract assessments and drafts, enforced vendor management processes, and upheld stringent document control standards. Established and maintained a robust supply chain and logistics framework to ensure product quality and regulatory adherence.

• Product Development ScrumMaster: Developed custom eCommerce storefront with enhanced AI integration and secure 2FA login and payment gateway delivering early value to the customer.

• Strategic Compliance Initiatives: Developed and implemented comprehensive Packaging, labeling, Educational & Training videos, art, IFU, and advertising programs, aligning with US EPA documentation, Design, Product Claims, Efficacy and regulatory requirements. Enhanced information security and data integrity. Expertise in Regulatory Frameworks: Acquired in-depth knowledge of EPA pesticide regulations, including 40 CFR part 158, and mastered the EPA’s FIFRA Pesticide Registration Manual and CFR 40 Parts 150 to 189. HotStyle Takeover Web & Software Design, Oakland, CA May 2014 – Aug 2020 Pro Bono Web Development Services: Product Owner, BA, ScrumMaster, Kanban, Lean, XP, PMP

• Dynamic and Detail-Oriented Web Development with a knack for conceptualizing and delivering elegant free websites for small businesses looking to move online before & during the Covid-19 pandemic, enhancing their digital presence and accessibility.

• Focused on best Agile Practices: delivering value quickly, product backlog refinement, risk prioritization, sprint planning, Sprints, standup meetings, removing impediments, reviews, continuous improvement through retrospectives.

• Spearhead global software Development Teams: Engineer user-centric solutions, achieving breakthrough efficiency and driving client value and satisfaction.

• Moved between various Agile Methodologies: Lean Thinking, Kanban, XP, Scrum, Hybrid and Waterfall approaches depending on project specifics goals, always delivering value early and often, eliminating waste, building in quality, process improvement and empowering the Team.

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• Utilized tools such as Jira and Confluence, MS Project: Manage burnup /burndown charts, roadmaps, cumulative flow diagrams, velocity, defect rates, release plans, milestones, and budgets.

• Developing Early Value: Delivering fully-functional websites. Armed with an extensive understanding of end-to-end SDLC, Cloud based products: CMS, PaaS, SaaS, WordPress, Salesforce, COTS software, plugins, e-commerce apps, ChatBots AI and CRM.

KPMG, Insight Consulting Partners, San Francisco, CA Dec 2015 – Feb 2017 Consultant Sr. Enterprise Program Manager

• Strategic Operational Analysis for PG&E Processes: 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. County of Alameda GSA (Information Systems & Technology), Oakland, CA Nov 2014 – Oct 2015 Project Manager - Business Analyst

• Project Management - Led First County-Wide Software RFP: procurement of a new CMMS Software solutions and website applications across county departments. Complex RFI/RFP: Managed the development and procurement of a new CMMS Software solution, with a focus on data migration, API integration, and ensuring accurate data distribution to key departments such as Accounts Receivable.

• Development of complex Government RFP: Special detail to SOW, product configuration, KPIs, adoption, method of procedures (MOPs), meeting the specific requirements of multiple departments within the County and adhering to contractual and regulatory compliance guidelines.

• Stakeholder Engagement and Communication- Agile Leadership: Partnered with IT and departmental leaders to define and implement API integration, ensuring real-time, accurate transfer of critical data between legacy systems and the new platform. Established clear communication channels with stakeholders to keep them informed about the software transition process; addressing concerns or questions, ensuring a seamless change management process.

• Led requirement gathering, wireframe and prototyping sessions with stakeholders to capture comprehensive and precise user and regulatory requirements. Developed business cases, SOW, defined selection criteria and assist in the creation of special terms and conditions for CMMS, SaaS software projects.

• Risk and Data Security Management: Managed comprehensive risk analyses, ensuring data integrity and security during critical cloud migrations and contractual negotiations. Focused on Risk Management & Information security (infosec), maintaining and controlling confidentiality, integrity and availability of IT systems, migrating business data, and including futureproofing qualities within the RFP/ SOW. Consulted with various Federal and state agencies gathering best practices and lessons learned on similar implemented software solutions to include in a complex regulatory compliant RFP.

• Adoption Monitoring and Reporting: Included RFP details for monitoring software adoption rates and user engagement through metrics and analytics tools. Developed a detailed training plan tailored to different user groups, including hands-on training sessions, e-learning modules, and user manuals. Also included ongoing support through helpdesks, FAQs, and user forums to assist users during the transition and adoption phases. AT&T TECHNOLOGY OPERATIONS, San Francisco, CA, Charlotte, NC / Atlanta, GA Apr 2010 – Nov 2014 Consultant IT Program Manager Network Development

• High-Stakes Project Leadership: Directed landmark $50+M infrastructure upgrades to IP, software development, and data center cloud migration initiatives, rigorously adhering to federal, state, and local regulations, and significantly enhancing network performance, quality, flexibility and security nationwide meeting the growing demands of users.

• Led MTSO Data Center Migration: Managed the comprehensive migration of MTSO data centers to cloud-based infrastructure, overseeing the deployment of Cisco Nexus 9000 Series switches, Juniper MX Series routers, and Ciena 6500 Packet-Optical Platforms. Applied PMBOK principles to meticulously plan, execute, and monitor the migration, ensuring minimal disruption, adherence to project timelines, and alignment with AT&T’s network scalability and performance goals. Nationwide Analog to IP Migration: Spearheaded the transition from analog to IP across multiple cell sites, deploying Cisco SIADs and replacing legacy TDM switches, Base Station Controllers and supervised the setup of Ethernet and fiber optic interfaces. Integrated SIADs and MTSO Equipment with Network Management Systems: Managed the integration of SIADs and MTSO infrastructure with AT&T's network management systems, including the setup of SNMP settings and secure API endpoints for remote monitoring and management. This upgrade significantly enhanced network performance, scalability, and security.

• Cross-Functional Team Management & Stakeholder Management: Led cross-functional teams, vendors, including network engineers, field technicians, General Contractors, software developers, and security experts, ensuring effective collaboration and communication among stakeholders. Coordinated with regulatory compliance teams to meet federal, state, and local standards.

• Advanced Schedule and Cost Management: 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. Connie O’Grady: Page 3 of 4

• 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.

• Comprehensive Risk Management: Identified, assessed, and mitigated risks throughout the migration process, developing contingency plans and conducting regular risk reviews. Implemented detailed rollback strategies to ensure proactive management and successful project outcomes. Implemented Robust Security Settings: Spearheaded the configuration of access control lists (ACLs), user authentication methods, and encryption protocols (IPsec), ensuring both SIADs and MTSO equipment were secure from unauthorized access – maintaining compliance at all levels.

• Agile Development and Implementation: Scrum - XP API, and ACL software development, conducted spikes to eliminate risks. Focused on best practices for critical development. Scrum Ceremonies / Continuous Improvement: sprint planning, prioritizing risks, facilitating daily stand-ups, resolving impediments, Reviews, Retrospectives, Backlog Refinement

• Documented and Finalized Configuration: Ensured all configurations and settings applied during the SIAD and MTSO provisioning were thoroughly documented in AT&T’s network management system, facilitating future reference and troubleshooting.

T-Mobile PMO / Concord, CA / Downers Grove, IL Jan 2007 – Apr 2010 Consultant / Senior Enterprise Program Manager

• Fiber to the Cell Site / Compliance / Development PM – UMTS, AAV, HSPA, 2ND Carrier. Retained to successfully manage Upgrade / Fiber Project, Cisco Siads, Switch upgrades leading to LTE 5G to ensure existing site stability, reliability and security.

• Lead and collaborated with cross-functional deployment teams to achieve goals by coordinating projects among Operations, Engineering, Techs, Construction, Compliance, Leasing, Zoning/Permitting, Project Controls, Subcontractors, A&E

• Managed thousands of miles of Fiber install in 7 Midwest Markets

• Detail the key deployment steps, milestones, timelines, and required resources in a concise project plan.

• Compliance and Regulatory: secure all local, state and Federal Entitlements

• Responsible for providing schedules, schedule updates, schedule tracking, and reporting activities for all events associated with all disciplines.

Bechtel / Cingular/ AT&T Pleasanton CA Jan 2003 - Jan 2006 Regional Wireless Manager / Site Development Manager

• Effectively managed greenfield / residential / commercial Real Estate wireless telecommunication site installs and upgrades in various markets. Lead and collaborated with cross functional deployment teams to achieve goals and timeline by coordinating projects among large diverse cross functional team. Education

• CSU San Marcos, BS Sociology San Marcos, CA

• Chapman University School of Law Contracts Orange, CA Technical Skills

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

• Jira Workfront Adobe Elements /Photoshop

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

• Google Cloud: Contact Center AI/ML Google Sheets Google Docs

• Smartsheet

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