Senior Systems Specialist

Key Responsibilities:

• Collaborate with internal stakeholders and external partners to ensure accurate project planning, compliant implementation, and successful deployment of solutions.
• Partner cross-functionally with teams to gather detailed requirements and convert them into scalable, compliant solutions.
• Define and manage project timelines, resource allocation, and key deliverables across the entire lifecycle.
• Lead validation efforts by overseeing creation of validation plans, protocols, and other documentation in alignment with regulatory guidelines.
• Ensure submission readiness through structured workflows, lifecycle management, and integration with regulatory systems.
• Oversee user access, role-based privileges, and audit trail configurations to uphold system security and compliance.
• Own change control for the system aligned with ITIL best practices, 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, and resolve issues with minimal business impact.
• Drive continuous improvement initiatives to optimize usability, performance, and compliance.
• Track KPIs and provide regular updates on system performance, adoption, and throughput.
• Contribute to roadmap planning, identifying integration opportunities with tools and 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 project tracking and service management tools for effective collaboration and communication.
• Maintain technical documentation including design, deployment, operations, and disaster recovery procedures.
• 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.

Required Qualifications:

• Doctorate degree OR Master's degree OR Bachelor's degree with 8-13 years of relevant experience in Computer Science, IT, or related field.

Essential 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 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.

Nice-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.

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.

Work Schedule:

• Must be willing to work during evening or night shifts as required by business needs.