Sr Spec, IT COE Apps

Vantive is seeking a Senior Techno-Functional Consultant with expertise in R&D application implementations to support digital transformation initiatives. The ideal candidate will be the SPOC of designated information technology systems, including but not limited to hardware, software, databases, & applications.

The ideal candidate will have expertise in R&D Application management and administration, the ability to manage customizations, and a strong understanding of product development lifecycles in regulated industries such as medical devices, healthcare, or manufacturing.

Key Responsibilities:

System & Incident Management:

• Monitor system performance metrics, identify areas of improvement, & implement optimization strategies to enhance efficiency and reliability.
• Identify and mitigate risks associated with system operations, data integrity, and/or cyber security threats.
• Alert and escalate technical issues, concerns to functional leads, architects, and/or program leads.
• Communicate with incident commanders and service desk in accordance with SLA's.
• Implement disaster recovery plans, backups, and system monitoring.

Continuous Improvement:

• Collaborate with BRM/MRM, EA, business owners, other IT functions, and/or with 3rd party system owners on system enhancements and capabilities to translate business requirements into technical designs that are globally scalable aligning with organization road maps, goals, and initiatives.
• Implement system upgrades and enhancements to improve systems performance, functionality, and/or security.
• Ensure the system is secure and up to date (patching, version, certificates etc.,) and the system is compliant with authentication policies.

Compliance & Validation Support

• Ensure applications deployments meet GxP and FDA 21 CFR Part 11 standards.
• Assist in computer system validation (CSV) activities, including IQ/OQ/PQ documentation and audit readiness.
• Support internal and external audits by providing system documentation, access reports, and validation artifacts as required
• Develop and maintain system risk assessments, validation scripts, and traceability matrices.

Implementation & Configuration

• Serve as the primary owner and subject matter expert (SME) for R&D Applications, including its core and extended modules
• Perform system configuration, customization, and validation. Administer user roles, access controls, licensing, and routine system audits to ensure compliance and uptime.
• Develop and implement standard operating procedures (SOPs), templates, and user access controls for compliance and efficiency.
• Conduct user training sessions, workshops, and documentation development to drive system adoption.

Qualifications & Experience:

Required:

• Bachelor's degree in computer science, Computer Engineering, or other related fields.
• 10 + years of experience in Information Systems, experience in multiple areas of IT.
• 5+ years of hands-on experience with R&D systems, including administration, customization, and integration.
• Ensure the system is secure and up to date (patching, version, certificates etc.,) and the system is compliant with authentication policies.
• Proven experience operating in multi-region environments (EMEA,APAC,LATAM) and hybrid cloud/on-premises architecture
• Familiarity with software development tools and methodologies, including version controls systems, and testing frameworks.
• Understanding of product lifecycle processes, including design control, change management, and document management.
• Experience with administration and maintenance of CI/CD and DevOps tools, including managing user accounts, performing system upgrades, handling license and certificate renewals, and ensuring high availability and security compliance across environments.
• Experience working in regulated environments with knowledge of relevant compliance frameworks.

Additional Skills:

• Basic project management experience (Agile, Waterfall, or hybrid methodologies).
• Strong problem-solving and analytical skills to address complex system issues.
• Excellent communication and stakeholder management skills.