SENIOR RA/QA PROJECT/CHANGE MANAGER | June 2018 – Present

Bio-Rad Laboratories, Inc. Hercules, Ca.

As a Senior Regulatory Affairs (RA) Project/Change Manager I hold a multifaceted role that involves overseeing regulatory-related projects. Maintaining compliance, ensuring product quality, and managing projects and changes within an organization. My responsibilities encompass a wide range of activities related to regulatory affairs, quality assurance, project management, and change management. Below are my key responsibilities:

• Project Management: Plan, execute, and close projects within scope, budget, and schedule constraints. Develop detailed project plans, including tasks, milestones, resource allocation, and timelines. Coordinate cross-functional project teams, ensuring effective communication and collaboration among team members. Monitor project progress, identify, and address issues, and implement corrective actions to keep projects on track.

• Change Management: Develop and implement change management strategies to ensure smooth transitions for organizational changes, process improvements, or system implementations. Assess the impact of proposed changes on processes, products, and stakeholders. Develop change management plans, including communication strategies, training programs, and stakeholder engagement activities using Prosci.

• Documentation and Reporting: Maintain accurate and up-to-date documentation related to regulatory submissions, quality processes, project plans, and change management activities. Prepare reports and presentations for stakeholders, providing updates on regulatory compliance, quality metrics, project progress, and change management outcomes.

• Project/Change Manager: Pivotal role in ensuring regulatory compliance, product quality, and successful project and change implementations. Navigate complex regulatory projects i.e., REACH (Substances of Very High Concern), RIMS implementation, Global COO/Submission for Manufacturing relocation. Maintaining high-quality standards, and managing projects and changes effectively contribute significantly to the organization's overall success.

​​

SENIOR GLOBAL PROGRAM MANAGER | April 2016 – June 2018

Bio-Rad Laboratories, Inc. Hercules, Ca.

As a Senior Global Program Manager, I was responsible for overseeing and managing a cloud-based Program (SCP), a complex, international program. The program facilitated on-demand product search, selection, and checkout applications at the customer's location. Played key roles in the development, leadership, strategic thinking, and coordination of the program. Below are some of my key responsibilities:

• Program Leadership: Provided strategic leadership and vision for the Supply Center global program, ensuring alignment with the organization's goals and objectives.

• Stakeholder Management: Build and maintain relationships with key stakeholders, both internal and external, including IT, Product Management, and R&D, customers, partners, and vendors.

• Program Planning: Develop comprehensive program plans, including sales objectives, software updates: scope, timelines, budgets, and resource allocation. Create a detailed roadmap for program execution.

• Risk Management: Identified potential risks and issues related to the program and develop mitigation strategies. Continuously monitor and assess risk throughout the Supply Center lifecycle.

• Global Coordination: Manage program activities across different geographical regions, accounting for cultural, regulatory, and logistical differences. Ensure global teams are aligned and communicate effectively.

• Budget and Financial Management: Oversee the program's budget, tracking expenses, and financial performance. Adjusted as necessary to ensure the program stays within budget.

• Program Monitoring and Reporting: Establish key performance indicators (KPIs) and metrics to track program progress and success. Provide regular status reports and updates to senior management and stakeholders.

• Change Management: Effectively manage and communicate changes within the program to all stakeholders, ensuring a smooth transition and minimal disruption.

• Issue Resolution: Addressed and resolved program-related issues and conflicts that arose during the program.

• Strategic Alignment: Ensure that the program's objectives and outcomes align with the organization's long-term strategic goals.

​

SENIOR ERP BUSINESS ANALYSIS |August 2011 – April 2016

Bio-Rad Laboratories, Inc. Hercules, Ca.

As an Enterprise Resource Planning Business Analyst, I played a crucial role in implementing and managing the SAP/ERP system within the organization. Acting as a bridge between the business side of the organization and the technical aspects of SAP/ERP system, provided technical and process solutions for the customer and vendor master.

• Business Requirements: Worked closely with business stakeholders to understand their requirements and translate them into functional specifications. Developed a deep understanding of the business processes within the Order to Cash, and Master Data organization.

• Gap Analysis: Conducted gap analysis to identify the differences between the organization's existing processes and the functionalities offered by the SAP/ERP system. Played a major role in customizing the SAP/ERP solution to meet specific business needs.

• Customization and Configuration: Configured the SAP/ERP customer master and vendor master system to align with the organization's processes. Additionally, supported the material master strategy for the GTIN implementation. Customizing modules, defining workflows, and setting up data structures and standards.

• Testing: Responsible for the customer and vendor master integration testing, and user acceptance testing of the SAP/ERP module to ensure that they function as intended, as well as defect solutions.

• Training: Conducted global training for all end-users and other stakeholders on how to use the customer and vendor segments of the SAP/ERP system. Created all training materials, conducted workshops, and provided ongoing support to users.

• Documentation: Documented global business processes: SOP/WI and QRG related to the SAP/ERP system configurations and customizations made to the SAP/ERP system.

• Support and Maintenance: Provided ongoing support to users, addressed technical and functional issues, answered queries, and troubleshooted problems. Monitored system performance and recommended improvements and/or upgrades as necessary.

• Continuous Improvement: Identified opportunities for process improvements and efficiencies within the organization. Developed a deep understanding of the business and the SAP/ERP system capabilities, suggesting enhancements to optimize existing workflows.

• Collaboration: Collaborated with cross-functional teams, including IT professionals, consultants, and vendors, to ensure seamless integration and operation of the SAP/ERP system.

                         
                                                       EARLY CAREER HISTORY AT BIO-RAD LABORATORIES, INC. 

INTERNATIONAL PRODUCT MANAGER II | August 2009 – August 2011

Bio-Rad Laboratories, Inc. Hercules, Ca.

• Oversaw the management of the company's primary diabetes and hemoglobinopathy platforms and software. Developed training programs focusing on competitive advantage, global sales, and brand strategy. Managed all tactical-related product management activities for the diabetes and hemoglobinopathy product line, ensuring their effective implementation.

• Formulated market positioning and sales strategies by conducting thorough market research, analyzing customer feedback, and assessing the competitive landscape.

• Worked closely with a diverse cross-functional team to address technical issues, manage inventory, define requirements, and implement updates.

• Collaborated extensively with technical service and support teams, marketing colleagues, vendors, customers, and Sales Representatives to enhance system functionality and overall performance, ensuring a seamless experience for users and customers alike.

ACCOUNT MANAGER/SALES REPRESENTATIVE | May 2007 –August 2009

Bio-Rad Laboratories, Inc. San Diego, Ca.

• In my role as the Sales Account Manager for the San Diego, Riverside, and San Bernardino territories, I was responsible for selling the Clinical Diagnostic product portfolio and achieved notable accomplishments, including:

• Recipient of the Presidents Circle Sales Award

• Successfully turned a deficit territory into generating over $1.6M in revenue.

• Established and nurtured relationships with 3rd-party Representatives and customers' Account Executives to effectively close sales opportunities.

• Utilized strong customer relationships, consultative skills, and problem-solving abilities to drive revenue growth and expand market share.

• Developed in-depth knowledge of the Clinical portfolio to better serve clients and meet their specific needs.

• Prepared and delivered quotes/bids to laboratory managers and support staff, ensuring accurate and competitive offerings.

• These achievements underscore my ability to excel in sales, build robust relationships, and contribute significantly to revenue generation.

​​

SENIOR DIAGNOSTICS SYSTEMS SPECIALIST | Oct 2003 – May 2007

Bio-Rad Laboratories, Inc. Los Angeles, Ca.

During my tenure as a Senior Diagnostics Systems Specialist, my responsibilities included ensuring the seamless installation, training, validation, and verification of the Clinical Diagnostic portfolio in the Western Region. This role involved several key tasks:

• Installed, validated, and verified clinical instrumentation: Oversaw the precise installation and validation processes for clinical instruments, ensuring their proper functionality.

• Provided on-site technical support and training: Offered

hands-on technical support and comprehensive training to customers, ensuring they were proficient in operating the diagnostic systems.

• Collaborated with Field Support: Worked closely with Field Support teams to investigate and resolve technical and chemistry-related issues, ensuring prompt and effective solutions.

• Conducted customer technical and functional training: Led technical and functional training sessions for customers, enhancing their understanding of the diagnostic systems and optimizing their usage.

• Documented technical issues and completed service-related documentation/reports: Maintained meticulous records by documenting technical issues and completing service-related documentation and reports, ensuring comprehensive and accurate records of all activities.

 

TECHNICAL SUPPORT REPRESENTATIVE II | Aug 2000 – Sept 2003

Bio-Rad Laboratories, Inc. Benicia, Ca.

As a Technical Support Representative II from August 2000 to September 2003, my role involved handling technical and clinical chemistry-related inquiries. Here are the key responsibilities I managed during this time:

• Responded to inquiries related to technical and clinical aspects, providing expertise and assistance to callers seeking guidance.

• Technical support liaison and Customer Complaint Representative: Acted as a crucial link between technical support and customers, addressing concerns related to instrumentation, software, chemistry, and training. Also, served as the representative for customer complaints, ensuring swift and effective resolutions.

• Generated and provided technical field bulletins and customer-related documentation: Created informative technical field bulletins to keep internal teams updated on the latest developments. Additionally, generated customer-related documentation to provide clients with the necessary information, ensuring clarity and understanding regarding the diagnostic equipment and its applications.

In this capacity, I played a vital role in providing technical expertise, managing customer complaints, conducting essential clinical trials, and facilitating effective communication between technical support and customers.