Immunomedics, Inc.

  • Head CMC Business Technology & ERP (Dir level)

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(1 month ago)
    Job ID
    2018-1280
    # of Openings
    1
    Category
    Information Technology
  • Overview

    This position will be responsible for building and leading the Technology function for the CMC (CTO office) and QA business units including responsibility for the enablement of all CMC, Manufacturing, QA and Facilities related systems.

    This role will work in close partnership with the CMC/CTO and QA leadership and business stakeholders to define, implement and support the CMC, Manufacturing and QA IT strategies defining a technology roadmap and partnerships that deliver on these respective business strategies. An ability to develop relationships as a trusted advisor and consultant with these  stakeholders is key as is a strong project management skillset with a record of successful delivery

     

    This role will also be responsible for design, implementation, and enablement of the ERP strategy and platform/capabilities to ensure enterprise level management of the company’s ERP data and information assets including the Finance, Supply Chain, HR and Asset Management functions to a single ERP system across all business partners.

     

    This individual will provide leadership (direct and indirect) to the resources needed to deliver on the capabilities encompassed within ERP  well as driving proper information management practices generated by the new ERP systems and processes.

    This individual will collaborate closely with business stakeholders to understand and anticipate business needs, define requirements, and identify, implement and support innovative technology solutions that allow Immunomedics to accelerate the pace of discovery, development, manufacturing and bring important new medicines to the patients we serve.

    The successful candidate will bring significant prior experience as a leader, defining and delivering IT solutions for CMC, Manufacturing and Quality in a pharmaceutical setting, The Sr. Director/ Director, CMC & QA Business Technology will lead a small team of professionals and vendor partners to build and manage the CMC & QA IT  and ERP application roadmap and portfolio

    Responsibilities

    • Responsible for the delivery of an ERP platform to manage and deliver the data and information assets of the organization
    • Establish a strong ERP Governance model to ensure systems are used efficiently, profitably and securely and plays a lead role in ERP governance across Immunomedics
    • Manage IT strategy, application roadmap, and project portfolio for CMC, Manufacturing and QA functions including solutions like BMS, BlueMountain, LIMS, QualityDocs, QMS. Work with CMC, QA, Business Technology, and Finance partners to prioritize efforts to best align with function and company goals and to align with overall Business Technology strategy and architecture.
    • Proactively partner with business units across the CTO and QA offices to identify needs and appropriate information technology solutions, documenting requirements and working with business stakeholders to build RFI/RFPs and business cases where appropriate.
    • Manages strategic program and project interdependencies across the CTO and QA organizations in partnership with the PMO
    • Assists Head of Business Technology in building the CMC, Manufacturing, Facilities, and QA components of the IT strategy aligned with business strategy.
    • Drives Business Value Realization through Technology roadmap
    • Build project plans, engage resources, and drive implementation projects to successful completion, meeting well defined requirements, managing scope, and keeping within project schedules and budgets;
    • Reports to senior management on information systems plans, projects, performance, and related matters.
    • Drives Portfolio Financial Management, managing the IT Portfolio Budget, aggregates strategic initiative financials, delivery performance, risk and issue reporting.
    • Collaborate with the Regulated Systems Support and IT Compliance group and Quality Systems Compliance, using risk-based approaches to validate GxP computerized systems while following company standards and ensuring the validated state of systems is maintained as systems transition into production.
    • Working with a mix of internal staff, contractors, managed services providers, and vendor resources, ensure successful delivery of technology support across the CMC/CTO IT application portfolios, including incident, problem, and change management processes that impact the portfolio, meeting applicable SLAs.
    • Provide vendor management and oversight for in-scope technology vendors, conducting regular vendor reviews and ensuring applicable metrics are collected and Accountable for the management of the CMC/CTO office IT budget developed and managed in line with the Enterprise IT and finance guidelines and processes. Continuing to assess services over time to identify savings opportunities and implementing a sourcing strategy that makes effective use of internal, external, and contract resources
    • Works to deliver innovative technology solutions that position the organization with a competitive advantage through decreased costs, streamlined processes, minimized support/effort and speed to market
    • Drives/Leads the Performance Management for the CMC/QA Business Technology organization (Scorecard, Goals, metrics, KPI’s)
    • Drives the change management for Programs enabling business capabilities in the CTO and QA domains
    • Spearhead and develop ERP lifecycle plans. Prioritize related initiatives and coordinate the evaluation, deployment and implementation of current and future ERP functionality.
    • Lead and manage the business analysis, roadmap development and guide all product activities for the ERP product portfolio
    • Oversee all aspects of ERP Application integration/configuration including functional and technical specifications, design, development and support for applications that are used by the business.
    • Oversee trends and developments in ERP technologies and formulate strategic courses of action
    • Responsible for development of the ERP strategy, trends and developments in ERP technologies and formulating strategic course of actions encompassing
    • Manufacturing
    • Supply Chain
    • Accounting and Finance
    • HRIS
    • Accountable for a budget of $ 10 M
    • Manages an organization between direct reports, consultants, contractors and managed services of partner vendors of approximate 10 to 20 global resources
    • Reports to the Head of Business Technology & Information Solutions Department and/or the most senior head of technology in the company.
    • Strong business acumen and knowledge regarding CMC, Manufacturing, Supply Chain, Quality Laboratories Supply Chain, and QA business area.
    • Strong knowledge and experience in ERP from design to implementation from Finance/Accounting to Manufacturing and good knowledge of HRIS in a GMP-regulated industry
    • Superior communication and listening skills with people at all levels of the organization.
    • Ability to promote an accountable and collaborative team-based environment.
    • Strategic thinker with ability to articulate vision and execute well.
    • Must be able to clearly explain concepts and value of project portfolios.
    • Strong and proven influencing, persuasion and negotiation skills.
    • Strong leadership skills to influence stakeholders and promote Programs value.
    • Proven ability to build and maintain strong collaborative relationships with managers across the business.
    • Demonstrated ability to effectively manage multiple simultaneous projects and deliverables in a cross-functional environment.
    • Ability to quickly adapt to changing priorities, assignments and roles.
    • Being a change agent – Understanding the importance of change management and the critical role that communications plays in driving change

    Qualifications

    • Bachelors in Computer Science, Information Technology or a related field with prior experience working at a pharmaceutical/biotechnology company. MBA or other relevant graduate degree is a plus.
    • Minimum of 15 years of experience in Information Technology arena with at least 10 years management and strategic experience including in support of CMC, Manufacturing and QA business functions
    • Minimum of 8 years of experience with ERP implementations in a heavily regulated, compliance-driven enterprise environment, preferable GMP, and a strong track record of delivering complex projects across multiple departments. Experience in Tier-1 SAP and Oracle, as well as GP and Dynamics strongly desired.
    • Subject matter expert in the CMC and QA Pharmaceutical/Biotech business - Demonstrated ability to manage manufacturing plant IT operations and Quality laboratory systems operation is required.
    • Previous practical experience executing validation projects for GxP systems, including conducting risk assessments, designing validation strategy, and authoring validation deliverables.
    • A thorough understanding of the entire Manufacturing life-cycle and the business deliverables of the QA function across the company with an ability to understand business requirements and translate them into practical solutions.
    • Pharmaceutical related supply chain experience and preferably within a global organization
    • Distribution operations and import / export compliance and international transportation experience
    • Contract manufacturing experience, including CMOs and third-party logistics providers
    • Experience in business analysis, process analysis and gap analysis.
    • A highly collaborative and solution-oriented leadership style that promotes teamwork and emphasizes business goal alignment and staff development.
    • Advanced communication and presentation skills with an ability to adjust to both technical and non-technical audiences including business stakeholders and senior management.
    • Ability to manage competing demands in a fast-paced, dynamic environment where collaboration, communication, prioritization, and flexibility are key attributes for success
    • Experience managing a team of professionals with a record of developing staff and building a high performing team
    • Have managed at least a minimum budget of $ 10 M and have manage global resources
    • Experience managing multiple projects, including partnerships with external technology partners, simultaneously from design through deployment.
    • Prior experience building and leading teams who tackle complex problems and perform broad technology implementations enabling the achievement of business goals
    • A proven track record in delivering change and transformation projects and their associated benefits to an agreed time-line, budget and quality.
    • Broad based leadership and general business management experience gained in a variety of assignments, functions, and business environments including distributed team and remote management.
    • Experience in financial management and budget planning as well as contract negotiation, vendor management including controls and service levels

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed