1eQMS Technical Solution Lead, Quality Systems

Position Summary

This position reports to the Program Manager – 1/eQMS. The eQMS Technical Solution Lead is responsible for leading the design, configuration, and implementation of the electronic Quality Management System (eQMS) to ensure alignment with defined business processes and regulatory requirements. This role serves as the primary liaison between business stakeholders and technical teams, translating business needs into scalable, compliant system solutions within the Vault platform.

The Technical Solution Lead provides both strategic oversight and hands-on configuration leadership across the full system implementation lifecycle, including requirements gathering, gap assessments, system configuration, testing, validation support, defect resolution, and training. This role ensures workflows, security models, reports, dashboards, integrations, and system configurations are implemented accurately and function as intended.

INDIVIDUAL CONTRIBUTORS:
•    Commitment to Goals –A strong commitment to achieving goals is essential for personal and team success. It requires taking ownership of tasks, staying focused on priorities, and consistently delivering high-quality work. Being proactive, managing time effectively, and seeking support when needed are critical to meeting deadlines and overcoming challenges. By aligning personal efforts with team and organizational objectives, individual contributors play a vital role in driving results and advancing shared goals.

•    Continuous Improvement - Continuous improvement means actively seeking ways to enhance your work, skills, and contributions. It's critical to stay curious, embrace feedback, and look for opportunities to streamline processes or solve problems more effectively. Individual contributors should take initiative to learn from experiences, adapt to change, and apply new knowledge to drive better outcomes. By consistently striving to improve, they add value to their team and support the organization’s growth and success.

•    Culture and Values – Living our culture and values is essential to fostering a positive, collaborative work environment. Individual contributors demonstrate this by treating others with respect, acting with integrity, and contributing to an inclusive and supportive team culture. It's critical to hold oneself accountable, align actions with shared values, and support the broader mission of the organization. By consistently modeling these behaviors, individual contributors help strengthen the workplace culture and positively influence those around them.

Principal Responsibilities

Provide routine status updates to the eQMS Project Manager and proactively identify and communicate risks to the project schedule.
•    Lead the translation of defined business processes into the Vault system, ensuring requirements are accurately documented, understood, and configured to meet business needs.
•    Facilitate and participate in gap assessments and process mapping sessions to determine how business processes will be implemented within Vault.
•    Facilitate the technical portions of Requirements workshops, including:
o    Business Process Requirements
o    Security Requirements
o    Reports, Dashboards, and Formatted Outputs
•    Collaborate closely with the Business Process Owner, Veeva Functional Analyst, IT Integration Lead, IT Data Migration Lead, IT Validation Lead, and Program Manager to ensure alignment with overall strategy and project plan.
•    Own and be accountable for Business Process Definition deliverables and serve as the primary collaborator with Veeva on configuration deliverables, including:
o    Field Inventory
o    Security Workbooks
o    Reports and Formatted Output Workbooks
•    Lead the technical execution of system configurations, including workflows, task automation, field configurations, permissions, document handling, and data security settings.
•    Partner with the Vault Configuration Specialist to ensure workflows and system components are configured accurately and in compliance with documented requirements.
•    Perform quality control of Vault configurations and test system workflows to ensure they function without errors and meet defined specifications.
•    Ensure technical customizations (e.g., field-level security, reports, dashboards) are implemented according to requirements provided by the Business Analyst.
•    Serve as the primary owner of testing activities, including:
o    Authoring and executing test scripts
o    Supporting SMEs during testing cycles
o    Preparing for and supporting ITC and UAT cycles
o    Performing quality checks on system outputs and related documentation
•    Support validation activities, including documentation review and execution support, as required.
•    Interface directly with the Veeva team on defect tracking, issue resolution, and configuration updates.
•    Provide technical troubleshooting and resolve system performance or workflow configuration issues.
•    Support training activities, including conducting instructor-led sessions for Train-the-Trainer and End User Training as needed.
•    Provide input to the eQMS project schedule to ensure technical activities are appropriately planned and sequenced.

Education / Experience Requirements

Bachelor’s degree in Information Technology, Engineering, Life Sciences, Quality, or a related field (or equivalent combination of education and experience).
•    3+ years of experience in Quality Systems with experience in regulated system implementations (e.g., Veeva Vault, TrackWise, MasterControl, or similar platforms).
•    1+ years of hands-on system configuration experience, including workflows, security models, field configuration, reports, and dashboards.
•    Experience leading or supporting full system implementation lifecycles (requirements gathering through validation and go-live).
•    Strong understanding of GxP, FDA, ISO, and other regulated environment requirements.
•    Experience supporting system validation activities (e.g., test script development, UAT, defect management, etc.)
•    Demonstrated experience facilitating Requirements workshops and/or cross-functional working sessions.
•    Experience collaborating with IT teams (i.e., integration, data migration, and validation teams).
•    Strong understanding of business process mapping and gap analysis methodologies.
•    Excellent written and verbal communication skills.

Specialized Skills / Other Requirements

•    Confidence in leading online and in-person meetings to present and discuss critical issues
•    Experience working directly with third-party vendors (i.e., Veeva) on configuration and defect resolution.
•    Proficiency with documentation tools (i.e., Lucid chart, Visio, Smartsheet).
•    Basic Project Management Experience is a plus but not a requirement
•    Standards and Regulations Knowledge

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