Manager Information Systems - Hyderabad / Secunderabad, Telangana - Amgen Technology Private Limited

    Amgen Technology Private Limited
    Amgen Technology Private Limited Hyderabad / Secunderabad, Telangana

    1 day ago

    Full time ₹400,000 - ₹1,200,000 (INR) per year *
    Description

    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.
    * This salary range is an estimation made by beBee
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