Immunomedics, Inc.

  • Head Systems Operations and Support (Dir./Sr.Dir Level)

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(1 month ago)
    Job ID
    # of Openings
    Information Technology
  • Overview

    The Head of Systems Development, Operations & Support provides leadership and direction in the design, implementation and support of business application systems throughout the organization. This is a highly technical role and will lead the application, development, maintenance and improvement of delivery operations for a portfolio of business applications to deliver IT service improvement to the business.

    This role will be accountable for ensuring the operational efficiency and effectiveness for all Service Operations and Applications Maintenance and Cloud SaaS applications support activities and architecture strategies. Will maintain responsibility for the overall operational health for all Applications company wide and policies in alignment with all compliance and regulatory demands for a biopharma company (i.e. SOX, 21 CFR Part11, HIPAA, GxP, GAMP-V, etc.).


    Directs, manages, plans and administers the operational and administrative activities of all Application Development, Configuration, Productions and Support. Manages a staff responsible for all phases of the systems development and implementation process. Primary responsibilities for the team is to manage integration development to / from Veeva and SFDC platform  and to /from other systems with a principal focus in GxP and Validated applications. Technologies include a mixture of SAAS solutions, on-premise, cloud-based data lakes, and enterprise tools, are in scope for this position. GxP validated systems, Key Responsibility for the development, delivery, and maintenance of technology solutions which drive business value for a growing enterprise!


    The Head of Systems Operations will partner with all business units and other IT leaders in the on-going development of Immunomedics’ applications infrastructure footprint. High Level Influencer Internally Focused


    Plan, prioritize, and manage the implementation of system upgrades to minimize disruptions to business activities and use the organization's IT resources effectively. Develop and implement a systems maintenance program to ensure the organization's systems function reliably. Research, evaluate, and recommend hardware, software products and cloud and SaaS architecture that will enhance the capabilities of the organization's information systems.


    Ensure that all information systems products and services meet minimum organization standards and end-user requirements. Administers change control process for zero defect software development. Ensures adequate product testing prior to implementation. Administers problem management process including monitoring and reporting on problem resolution.


    Manage ongoing relationships with external consultants and suppliers to ensure satisfactory standards of service. Lead, direct, evaluate, and develop a team of information systems 

    professionals to ensure the organization's information systems strategy is implemented on time and within budget.


    Responsible for all activities relating to the QA, audit, validation and compliance of information systems procedures and systems in partnership with QA and Validation units. Develops information systems audit & compliance programs and control guidelines. Additionally, oversees the execution of the Computer System Validation Master Plan and validations activities in partnership with the QA and Validation units.


    Reports to the Head of the Business Information and Technology Solutions department. He/she is a member of the BITS leadership team and serves a key role in Immunomedics.


    • Strategic development of all IT Applications, Cloud and SaaS initiatives through creative, cost-effective technology solutions that support and meet the business objectives of the organization. Ensure alignment between corporate and IT needs and objectives while focusing on best practices, awareness of emerging trends and striving towards innovative solutions that create a competitive advantage.
    • Responsible for overall Application Development/Configuration, Releases management, validation activities, operations, governance, production and support of Applications; and maintenance delivery of respective applications according to Service Level Agreements and address gaps with the business.
    • Report Application Development and Maintenance related performance to the business taking action where necessary to address performance issues.
    • Coordinates maintenance communications to the business (e.g. Incident alerts, change freezes etc.).
    • Approve operational readiness for projects and releases.
    • Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Ensure compliance with IT service management governance, standards and polices .
    • Champions change and innovation. Stimulates creativity and innovation in others. Open to new ideas. Supports those who initiate change and take risks.
    • Anticipates and recommends technical solutions to business problems. Accountable for effectiveness of systems solutions relative to business requirements.
    • Negotiates, secures, oversee & ensure that resources are available to meet the daily operational demands of the area.
    • Oversees and controls department budgets, project capital/RCE expenditures & ROI: develop, monitor and meet expense and recovery plans; continually look for opportunities for cost reductions and cost avoidance.
    • Responsible for all aspects of people leadership; setting expectations, coaching, counseling, developing, evaluating, feedback, hiring, discipline and separations. Determine necessary mix of skill set.
    • Establishes and maintains strategic level working relationship with functional counterparts in the Business Domain teams. Serve as the initial contact point for strategic initiatives initiated by Business Domain teams that require Application Configuration, Project Delivery, Production and support. .
    • Champion the development of standards and best practices cross functionally. Drive process efficiency and improve overall productivity by identifying gaps, and evaluating / implementing new ideas, tools and processes. Create mechanisms to proactively detect deviations from expected service levels and influence internal and external partners on improvement plans, including plan/build and architecture.
    • Manages the relationship with service provider team and delivery teams to ensure superior service delivery for all application maintenance and support activities.
    • Ensures all activities are completed following compliance and regulatory requirements (i.e. SOX, 21 CFR Part11, HIPAA, GxP, ISO, etc.). Ensure planning and prioritization, end user impact, change and quality management and training are properly addressed and managed to meet deadlines, budgets, service levels and results.
    • Establishes Standards and Procedures for SDLC, Cloud, production support, Security and Compliance.
    • Works closely with internal teams and external auditors to ensure compliance with FDA, GXP, HIPAA, SEC, SOX, ISO, and other applicable regulations as well as provide full support for any related audits, either internal or external.
    • Communicate sand Train continuously -- Create education and awareness programs and advise operating units at all levels on security issues, best practices, and vulnerabilities.
    • Accountable for a budget of $10 M
    • Manages an organization between direct reports, consultants, contractors and managed services of partner vendors of approximate 20 to 30 global resources.
    • Innovation skills and vision
    • Systems architecture, analysis and planning skills
    • Extensive expertise in overall SDLC, cloud architectures, environments and strategies along with associated methodologies to build, support and maintain in support of a GxP application environments
    • Superior leadership, collaboration, and communication skills with demonstrated ability to create and communicate a clear vision and shared purpose, build consensus, and maintain partner-style relationships with senior level management and key stakeholders.
    • Ability to effectively manage cross-functional teams or projects in designing and applying technology to create integrated, company-wide solutions that comply with regulations.
    • Demonstrated technical, organizational, project management, and negotiation capabilities. Must be a self-starter with accountability for and excellent ability to implement and execute.
    • Flexible ‘smart’ to manage and to adapt to shifting priorities, demands, and timelines.
    • Hands-on software development & configuration background. Willingness to dive into software environments and technical issues.
    • Strong understanding of the software development cycle and GAMP-V
    • Experience with leading the development of SaaS and cloud-based applications.
    • Preferred proven experience with ITIL, specifically Incident and Problem management as well as Continuous Improvement Planning (CIP), Demand and Release and Deployment Management. ITIL Foundation Certification. Experience developing and implementing Operating Level Agreements (OLA’s).
    • Preferred experience developing and implementing Operating Level Agreements (OLA’s). Experience with Service Operations in a global, multi-sourced environment. Demonstrated experience in establishing standard processes and improving performance to achieve key metrics. Strong fiscal management and budgetary skills.
    • Preferred extensive understanding and knowledge of ITIL-based IT service management best practices, as well as industry best practice IT support standards, strategies, solutions, and methodologies as well as emerging methods, such as DevOps, that are optimized for agility. Experience with Service Now
    • Preferred experience proactively managing an outsourced, third-party support vendor for a significant portion of support operations for a global business; Demonstrated Program and Project Management skills; Cross-domain knowledge (Finance, Sales, Marketing, Supply Chain)
    • Demonstrated experience in establishing standard processes and improving performance to achieve key metrics; Demonstrated excellence in problem solving and tackling complex issues that span multiple areas of responsibility and diverse technologies
    • Experience with Scrum methodology and Agile practices
    • Ability to successfully work under tight project deadlineson Performance Product Production QA Quality Assurance Release Service Statutory UX UI User Experience Interface Researcher Designer Service Project Software Test Program Programmer
    • Ability to operate at multiple levels of engagement, management to hands-on, as needed
    • Vendor relationship and negotiating skills
    • Business transformation and change management awareness.
    • Strong leadership, project management skills, time management, and problem solving skills
    • Self-motivated, team player, action-and-results oriented. Team building and conflict resolution skills
    • Demonstrated ability to coordinate cross-functional teams towards task completion. Experience with Service Operations in a global, multi-sourced environment. Experience in effectively leading cross-functional teams, influencing key stakeholders, across the organization and within complex contexts.
    • Effective influencing and negotiation skills. Strong vendor management and partner relation skills to identify and leverage resources internal and external to the enterprise to enhance capabilities that support business objectives. Experience in effectively leading cross-functional teams, influencing key stakeholders, across the organization and within complex contexts.


    • BA/BS in computer science, engineering, or business-related discipline with at least 15 years of progressive work experience in a biotech, pharmaceutical, or clinical research setting with direct responsibility for IT infrastructure, services, and support or relevant work experience.  Advance degree preferred.
    • Must have at least 10 years of experience working through the design, development, release cycle, and production support
    • Minimum of 5 years of management/ leadership experience in software development and support in a highly regulated and validation environment
    • Experience in architecting, designing and implementing integration with Veeva and/or SFDC Cloud/SaaS applications, GxP applications
    • A comprehensive knowledge of the IT industry and technology standards as applicable to regulated environments, along with a thorough understanding of current technology applications and solutions as well as emerging developments.
    • Technology exposure should include ERP, R&D Applications, Commercial Applications, SaaS, GxP systems
    • Experience in oncology and autoimmune diseases highly preferred.
    • Solid understanding of the applicable regulatory environment and industry standards.
    • #LI-BG1


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