Quality Systems Project Manager - Waukegan, United States - Infobahn Softworld Inc

Infobahn Softworld Inc
Infobahn Softworld Inc
Verified Company
Waukegan, United States

1 week ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
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 crossfunctionally 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 crosssystem 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.
  • 58 years' experience with quality assurance and/or quality system oversight.
  • Leadership of other technical professionals and experience in leading crossfunctional 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.

Job Types:
Full-time, Contract


Pay:
$ $58.00 per hour


Experience level:

  • 3 years

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Education:


  • Bachelor's (preferred)

Experience:

- quality assurance background: 5 years (preferred)

  • Knowledge of regulations: 5 years (preferred)
- quality compliance: 5 years (preferred)

  • Quality systems: 5 years (preferred)
- pharma or medical device or biotech industry: 5 years (preferred)

  • Manage quality system integration projects: 5 years (preferred)

Ability to Commute:

  • Waukegan, IL preferred)

Work Location:
In person
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