Leading end-to-end project implementation in a regulated biotech environment, ensuring all deliverables meet strict quality and GxP compliance standards across cross-functional teams (R&D, QA, GIS).

Driving strategic enterprise analysis, including root cause analysis and comprehensive business case development, to justify investments in laboratory automation and digitization projects aligned with strategic sequencing product goals.

Orchestrating and leading the full requirements lifecycle, collaborating with core stakeholders to translate complex needs unique to DNA sequencing workflows into precise functional specifications.

Serving as the principal functional expert for LabVantage LIMS, performing complex configurations focused on managing sample genealogy, batch records, and instrument data logging crucial for sequencing product quality control.

Specializing in implementing integrations between LIMS and critical enterprise systems, including Manufacturing Execution Systems (MES) and Enterprise Resource Planning (ERP), ensuring seamless data flow across the sequence-to-product value chain.

Deployment & Governance

Directing and coordinated ongoing application sustainment (upgrades, patching), managing efforts with GIS and Quality/Validation stakeholders to maintain system stability and compliance.

Oversee LIMS application and integration deployments, leading the post-launch hypercare phase and rapidly resolving issues to ensure seamless business transitions.

Maintaining proactive and transparent communication with a diverse stakeholder group, including senior management, providing high-impact status reporting and managing production support escalations.

Requirements and System Design

Gathered, analyzed, and documented functional and non-functional business requirements for client LIMS implementations, ensuring direct alignment with LIMS best practices, client objectives, and regulatory compliance standards.

Focused on workflow optimization, analyzing current client processes and designing efficient LIMS solutions to enhance laboratory productivity and data management capabilities.

Prepared and managed foundational documentation, including Functional Requirements Specifications (FRS), to serve as the blueprint for accurate system configuration and development.

Implementation and Client Guidance

Collaborated closely with Configuration Designers and Developers to accurately transfer and clarify functional requirements, facilitating effective LIMS configuration, custom development, and successful system integration efforts.

Coordinated with Project Management to track project timelines, key deliverables, and scope changes, helping to monitor and mitigate project risks throughout the implementation lifecycle.

Provided direct guidance to customers on master data setup, offering best practices for efficient data migration, system validation support, and end-user training to ensure project success.

Quality and Stakeholder Engagement

Facilitated customer workshops and working sessions to refine complex laboratory workflows and drive user adoption of the new LIMS solution.

Executed comprehensive Acceptance Test Plans (ATP), managing change requests, and coordinating system reviews to validate configurations, resolve outstanding issues, and ensure the final solution met all documented requirements.

Ensured a complete and smooth transition of the implemented system, including documentation handoff, to the internal Support Team for ongoing maintenance and sustainment.

Design and Requirements

Developed system architecture by analyzing project scope, processes, technical alternatives, and associated risks.

Analyzed and documented client requirements and processes using document review, interviews, and detailed workflow analysis.

Translated requirements into clear specifications by creating easy-to-understand data and process models.

Compliance and Quality

Ensured regulatory compliance by adhering strictly to Good Documentation Practices (GDP) and 21 CFR Part 11.

Managed and participated in all testing phases, including functional, regression, UAT, integration, and performance testing, to certify client needs were met.

Collaboration and Guidance

Collaborated with cross-functional teams to evaluate system design and resolve conflicts.

Acted as a consultant by providing best practices and industry lessons to separate essential user needs from non-essential 'wants.'

• Engage client to gather software requirements/business rules, and ensure alignment with development teams for the supplier enablement part of eProcurement initiative with SAP/Ariba.

• Identify and reconcile errors in client data to ensure accurate business requirements.

• Draft and maintain business requirements and align them with functional and technical requirements.

• Collaborate with stakeholders to gather software requirements/ business rules.

• Ensure alignment of requirements with vendor development teams.

• Translate stakeholder requirements different deliverables such as functional specifications, user cases, user stories, workflow/process diagrams, data flow/data model diagrams.

• Evaluate risks related to requirements implementation, testing processes, project communications.

• Draft and maintain business requirements and align them with functional and technical requirements.