Quality Systems Project Manager in Waukegan, IL

  • Title: Quality Systems Project Manager
  • Code: RCI-26060
  • RequirementID: 117737
  • Location: Waukegan, IL 60085
  • Posted Date: 05/08/2024
  • Duration: 12 Months
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  Job Description

Purpose:

  • Oversees the integration and implementation of quality assurance systems and activities across multiple global and regional quality functions.
  • Oversees evaluation of quality system processes and procedures from a GMP perspective.
  • May lead or participate in the management of integration activities across multiple disciplines including but not limited to Production process controls, suppliers & third parties, quality compliance and quality control.
  • Works cross-functionally to ensure quality processes are compliant, efficient, and meet global regulations pertinent to client product portfolio.

 

Responsibilities:

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

  • Plan, schedule, and control project activities to fulfill objectives and satisfy project requirements using appropriate project management tools and processes.
  • Manage quality system integration projects within established scope, schedule, and budget. Work cross functionally to drive business integration objectives.
  • Ensure effective use of meetings by clearly defining objectives, agendas, inviting the team members specifically needed and publishing minutes and actions.
  • Drive integration Quality projects across multiple functions in Operations Quality and the broader operations network; ensure subsystems are connected and cross-system dependencies are optimized/leveraged.
  • Drive implementation of harmonized policies, processes and procedures that integrate acquired companies into the quality system across the global network; define clear governance rules to remove redundancy and drive desired outcomes. Collaborate with partners in global and site roles across the network to drive broader network compliance and efficiency.
  • Establish and maintain Quality System communications that enable awareness of integration progress for area of responsibility and across multiple workstreams as required.
  • Create and maintain robust linkage between quality systems integration and manufacturing and global teams to drive harmonized, compliance and agile processes.
  • Lead the collection, verification and reporting of quality system integration metrics for report out to senior leadership.
  • Manage quality communication activities in association with Operations communications representatives to ensure the organization is appraised on key quality initiatives

 

Qualifications:

List required and preferred qualifications (up to 10). Include education, skills and experience.

  • Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical or scientific area.
  • 5-8 years’ experience with quality assurance and/or quality system oversight.
  • Leadership of other technical professionals and experience in leading cross-functional teams with results orientation. Skilled in the strategy development, initiation, selection, coordination, and management of projects and have the ability to solve unique problems.
  • Knowledge of regulations and standards affecting devices, combination products and Biopharma products.
  • Understands impact of changes to quality systems across a diverse network and ability to adjust accordingly.
  • Conflict resolution skills including persuasive management techniques required. Strong oral and written communication skills needed. Excellent interpersonal skills a plus.


About Rangam:

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