Quality System Remediation Program Manager

Title:     Quality System Remediation Program Manager

Type:     Contract relationship

Position information:

Experienced consultant(s) needed for large project and program management assignments across FDA- regulated product classes including pharmaceuticals, medical devices and biologics.  Core responsibility is to work with internal client executives and staff to help drive and manage project objectives in accordance with FDA requirements and expectations.

Demonstrated experiences / accomplishments should include:

  • Large, complex program management; consent decree a plus
  • Project and process management
  • Proficiency in Microsoft Project or equivalent project management tools
  • Business and financial acumen
  • Exceptional written and oral communication abilities
  • Quality systems assessment abilities
  • Team supervision including ability to drive team accountability for deliverables, develop and deliver team recommendations, create and meet project milestones and financial commitments
  • Develop project schedules, cross-functional deliverables, and detailed timelines and identify and manage project priorities and dependencies while providing progress updates
  • Collaboration with other project managers and quality system teams to deliver aggressive plans
  • Identification of execution gaps and ability to correct/redirect
  • Risk identification and mitigation

Preferred Education

  • Degree in engineering, pharmacy, bioengineering, medical technology, biology, chemistry or related technical discipline or management
  • PMP or a Project Management certification and/or Process Excellence certification is a plus

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