Empower CDS Business System Owner

Basic qualifications:

  • Bachelor's degree in scientific discipline or computer sciences or significant equivalent work experience.
  • 5 or more years experience in either managing IT applications in a regulated environment or in PDS Working Processes
  • Detailed Technical knowledge of Empower CDS
  • Experience in conducting business analysis/problem solving, defining business requirements for computer systems and information management improvement activities.
  • Experienced in understanding and complying with PDS processes and relevant regulations.

Preferred qualifications:

  • Expert in the use of Empower CDS.
  • Detailed Technical knowledge Empower
  • Technical experience in working with installation and configuration of hardware components associated with Lab Systems
  • Experience managing applications and deploying computer systems within a regulated environment
  • Expert in the use of multiple PDS computer Systems.
  • Knowledge of PDS Business Processes, particularly those supported by computer systems.
  • Experienced in understanding and complying with PDS processes and relevant regulations.
  • Experience in global project and/or product management.
  • Experience in data management, data integration, data mining, and analytics.
  • Experience delivering new scientific computing technologies to a scientific / regulated environment.
  • Familiar with pharmaceutical industry processes and regulatory requirements (e.g. FDA and EU GMPs, GAMP, Electronic Records & Electronic Signature rules).
  • Experience in strategic planning and customer engagement.
  • Good team working, networking and communication skills.
  • Able to work within a matrix environment with other members of the worldwide group.
  • Strong analytical and problem solving skills.
  • Proven ability to seek, monitor, and interpret customer needs and to manage and negotiate customer expectations from scientists to senior managers in business and IT.
  • Demonstrated interpersonal, communication, facilitation, negotiation, and presentation skills.
  • Able to handle a variety of tasks with complex variables, and be able to shift priorities as needed.
  • Passion for innovation and success.

Details:

Job Purpose:

  • Provide business centric expertise for PDS Systems and related business processes (where appropriate) through project management, business process understanding, technical proficiency, system administration and compliance knowledge, throughout the system life-cycle (Initiation, Development, Implementation, and Support).
  • To identify, manage and mitigate risks to the business, due to Systems based issues, by logging, tracking and addressing appropriately.
  • To serve as the central point of control (Business System Owner) for Empower CDS, and if required, for additional PDS applications developed and primarily supported by IT.
  • To ensure that the Empower CDS systems, and other PDS systems, if applicable, are fit for purpose and of an appropriate quality standard for use within the business and if supporting regulated processes, are validated and maintained in a compliant manner.
  • To ensure any development and enhancements are in line with PDS needs and implemented with appropriate change management, with clearly defined benefits.
  • Maintain an overall knowledge of Product Development & Supply work processes such that business needs can be easily identified, solutions recommended, and appropriate projects initiated.
  • Provide leadership and guidance to ensure that Empower CDS and other existing PDS systems are utilized in accordance with policy, business rules are instituted and required enhancement are actively pursued.
  • Maintain awareness of changes in the internal /external environments, new technologies and their potential for utilization within Product Development & Supply.
  • Business project lead responsible for management of interactions with R&D IT in the development and implementation of information systems; includes budgeting, resource management and adherence to timelines
  • Work closely with scientific staff to understand their business processes
  • Identify and recommend business process improvement opportunities to enhance end-user experience
  • Delivery of upgrades and enhancements to the Empower CDS application over lifecycle of system ensuring all technology designs and solutions meet the needs of the end users
  • Lead validation activities for Empower CDS in accordance with GMPs and 21CFR Part11 and ensure compliance over lifecycle of system
  • Manage communications between subject matter experts and scientific staff to ensure issues and training are addressed including knowledge sharing to solve simple, well defined problems
  • Coordinate downtimes for project related upgrades, updates, and configurations
  • Provide technical expertise for troubleshooting and incident resolution to user community, as well as, liaising with IT experts for problem management - including deep dives.
  • Ensure documentation is completed in support of activities, quality incidents and regulatory requirements (e.g., system SOPs, change controls, validation documentation).
  • Track and execute Empower CDS system periodic reviews, user account review and other computer compliance processes as assigned.
  • Responsible for fielding questions about the validation status of the Empower CDS system during a regulatory inspection or audit.
  • Maintain an overall knowledge of PD functions and processes to ensure effective change management for Empower CDS and other responsible IT systems.
  • To know and understand the scope of all company and local safety procedures and be able to determine their relevance to own work.

Contact information:

You may apply for this position online by selecting the Apply now button.

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