Description

  • 3 – 5 years (preferably in Medical Device or other Regulated Industry)
  • Technical background/ software systems
  • Validating experience
  • Quality Control
  • Change Control 
  • Veeva Vault content management applications)Nice to have)
  • Coding skill is a plus
  • Ability to manage projects, including planning, validation, and deployment.
  • Experience in configuring and administering a validated quality system.

Responsibilities

  • Manages the activities and people associated with the project and the success of that project.
  • Works with the user to identify the user's needs.
  • Delivers quality systems solutions to business problems.
  • Develops conceptual-level requirements in the analysis phase.
  • Supports the production environment proactively through tracking management activities.
  • Responsible for the ongoing systems needs of the client/user community.

Competencies:

  • Provide supervision; develop group goals and objectives; monitor and control client production charges; develop and evaluate staffing plans; utilizes formal SDLC to coordinate system development activities; provide project status reports; identify and define user needs; analyze project proposals; develop conceptual systems requirements; develop systems integration requirements; develop systems phasing plan; provide business application consultation; provide problem tracking/management; and prepare and deliver presentations.

Qualifications:

  • Bachelor's or Master's degree in Business, Information Services, or Computer Science preferred; four to six years consulting experience preferred.
  • Eight to twelve years' experience, including at least two years professional consulting and two years in program/project management; formal training in SDLC methodologies; good analytical and problem-solving ability, creativity, and insight; proven ability to motivate employees and create a positive working environment; strong interpersonal and communication skills and a strong political awareness

Education

Bachelor's or Master's degrees