Job
Description
Job purpose: As part of the Ocugen team, the GxP Systems Specialist will implement and manage the Ocugen Veeva vault and other GxP applications to meet regulatory requirements and business needs. The ideal candidate should bring experience working in enterprise application environments in life sciences with the ability to manage multiple projects across different functions. The candidate should also be experienced as a technical lead for IT (Information Technology) projects. Duties and responsibilities: Accountable for implementation/delivery of Veeva applications to meet Ocugen business needs with a focus on regulated functions: Serve as a subject matter expert in business and system administration with extensive hands-on experience configuring Veeva Vault platforms, including Quality, QMS, Training, Clinical, and RIM applications. Evaluate Veeva general releases, conduct assessments/proof of concepts (POCs), and develop business cases for implementing new enhancements or configurations to align with enterprise needs. Lead and oversee change controls, manage system deviations, and drive continuous improvement initiatives. Ensure all activities are performed in accordance with defined GxP processes and are appropriately documented to maintain compliance. Ensure critical system operations activitiessuch as access management, periodic reviews, configuration updates, and data integrity monitoring—are performed in compliance with established GxP procedures and operational standards. Support change management initiatives to ensure effective planning, communication, and adoption of new systems and processes. Liaise with computer system vendors, Quality, and business stakeholders to coordinate implementation activities, applying vendor management best practices. Help define project scope and deliverables to support business goals in collaboration with senior management stakeholders. Identify opportunities for innovation and process optimization based on evolving client and regulatory requirements Work with the business to develop and document system and user requirements aligned with GxP principles and 21 CFR Part 11 compliance. Define and oversee documentation of configuration and design specifications. Contribute to the authoring and execution of implementation plans, qualification tests, and computerized system validation (CSV) documentation. Develop and maintain CSV standards, procedures, and work instructions to ensure consistent execution and regulatory compliance. Provide support for internal audits and regulatory inspections by ensuring system readiness, documentation accuracy, and timely response to findings or queries. Provide support during U.S. business hours, as required, to ensure incident/issue system resolution across global teams. Management Of GxP Systems Lifecycle Management of system access and permissions. Perform change management activities. Design solutions and manage configuration. Liaise with users to resolve issues. Create reports based on defined requirements. Maintain system documentation. Build systems reports and dashboards. Propose standardization and harmonized approach for configuration. Manage major and minor release including risk-based approach for validation and implementation. Analyze user enhancement requests to deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and growth of the organization. Qualifications: Qualifications include: Bachelor’s degree in computer science or technology with at least 5+ years’ direct experience working with Veeva Vault Technologies implementation and establishing enduring Governance to drive strategic Product Roadmap Deliveries. Experience with the Veeva Vault Development Platform, including QDocs, Training, RIM, QMS, CTMS and cross-domain integrations. Experience and knowledge of quality and regulatory business processes. Direct hands-on experience implementing GxP computerized systems and maintaining validated state. Strong process improvement skills and orientation. Must have proven business and technology skills in successfully providing a customer-oriented technology solutions environment. Proven strong communication skills in interacting with users and technical communities. Ability to communicate ideas in both technical and user-friendly language. Collaborative working approach. Computer Skills: Certified Veeva System Administrator - Required. Veeva Vault Owner/System Administration Experience (Quality QMS (Quality Management System), Quality QualityDocs and Training, RIMS/Submissions, Clinical, Safety, Station Manager, Vault Mobile, etc.) Experience with Other Regulated Applications would be an asset Database and computer networking knowledge Experience working on SaaS (Software as a Service) systems Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethics; Upholds organizational values. Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction. Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information. Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts team success above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit, Shares expertise with others. Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Change the approach or method to best fit the situation. Able to deal with frequent changes, delays, or unexpected events. Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to build knowledge and skills continuously; Shares expertise with others. Dependability - Follows instructions, responds to management direction, takes responsibility for own actions, keeps commitments, commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies the appropriate person with an alternate plan. Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data. Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully. Project Management - Communicates changes and progress; Completes projects on time and budget. Working conditions: This position operates primarily in an office setting and may include 10% of travel. Physical requirements : This is a largely sedentary role.
