Roles & Responsibilities:
- Collaborate with internal Regulatory Operations stakeholders and vendor partner (Lorenz) to ensure accurate interpretation of requirements, compliant submission delivery, and successful deployment of the solution
- Partner cross-functionally with Regulatory Affairs, Quality Assurance, IT Security, and vendor teams to gather detailed business requirements and convert them into scalable, compliant solutions
- Define and manage project plans, resource allocation, timelines, and key deliverables across the entire lifecycle: assessment, procurement, configuration, validation, release, and support
- Lead validation efforts by overseeing creation of validation plans, IQ/OQ/PQ protocols, and other documentation in alignment with GxP, 21 CFR Part 11, and Annex 11
- Ensure submission readiness through structured document workflows, lifecycle management, and integration with systems like Regulatory Veeva Vault
- Oversee user access, role-based privileges, and audit trail configurations to uphold system security and compliance
- Own change control for the submission system aligned with ITIL, ensuring traceability for all changes, patches, and configurations
- Develop training materials and deliver user training sessions for onboarding and system adoption
- Monitor production performance, troubleshoot incidents with Lorenz, and resolve issues with minimal business impact
- Drive continuous improvement initiatives to optimize usability, performance, and compliance
- Track KPIs and provide leadership with regular updates on system performance, adoption, and throughput
- Contribute to roadmap planning, identifying integration opportunities with tools like Lorenz eValidator and regulatory intelligence platforms
- Serve as the SME for structured submissions during audits, inspections, and regulatory reviews
- Rapidly prototype solutions and translate concepts into functional code
- Adapt to agile methodology and lead cross-functional teams effectively
- Utilize Jira and ServiceNow for project tracking and service management
- Maintain technical documentation including design, deployment, operations, and disaster recovery
- Monitor system health, performance, and capacity using dashboards and tracking tools
- Implement and manage system security to guard against unauthorized access and vulnerabilities
- Respond to and resolve incidents, conduct root cause analysis, and implement preventive solutions
Basic Qualifications:
- Doctorate degree OR
- Master's degree OR
- Bachelor's degree with 8 to 13 years of relevant experience in Computer Science, IT, or related field
Must-Have Skills:
- Deep understanding of pharmaceutical regulatory compliance (FDA, EU CTR, GxP)
- Expertise with submission publishing systems, especially Lorenz docuBridge and Regulatory Veeva Vault
- Strong experience managing technology initiatives and cross-functional teams
- Proven ability to lead in dynamic, fast-paced environments with minimal supervision
- Familiarity with methodologies like ITIL and Scaled Agile (SAFe)
- Broad understanding of network technologies and IS architecture
- Excellent stakeholder collaboration and communication skills
Good-to-Have Skills:
- Knowledge of eCTD specifications and regulated system compliance
- Prior leadership experience in pharma or tech organizations
- Hands-on experience across the software development lifecycle of GxP systems
- Working knowledge of SAFe, Agile frameworks, and change control management
- Familiarity with IS governance practices and stakeholder alignment
- Broader understanding of enterprise architecture and infrastructure domains
Professional Certifications:
- ITIL (preferred)
- SAFe for Teams (preferred)
- Veeva Vault platform certification (preferred)
Soft Skills:
- Strong analytical and troubleshooting capabilities
- Effective verbal and written communication
- Ability to manage multiple priorities with strong self-motivation
- Team player with a collaborative mindset
- Confident in presenting to diverse audiences and leadership
Shift Information:
- Must be willing to work during evening or night shifts as required by business needs. This position may include second or third shift scheduling.
