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(Old Posting) Senior Manager, QA Compliance

Department: QA
Location: Cambridge, MA

Responsible for routine management and coordination of GXP compliant systems and provide leadership for quality compliance activities and initiatives.

Key Responsibilities:

  • Change Management project- Finalize and implement system
  • Evaluate and purpose changes to current Deviation and CAPA (Including Clinical) programs.
  • Develop a set of proposed Quality Metrics
    • Change Control
    • Deviations
    • CAPA
    • Audit Observations
    • Temperature Excursions (Shipping)
    • Disposition
    • Risk Assessment (High)
  • Develop proposal of Quality (Management Review) Council with implementation plan
    • Format
    • Frequency
    • CMC, Clinical or other
    • Periodic reports for management review on the status of compliance, and quality standards of all facilities, processes, procedures and practices
  • Lead QP certification activities
    • Project management leader
    • Tracking of action items and projects
  • Develop system for Quality Agreements
    • Procedure
    • Tracking
    • Template (generation)
  • Closure and archival of CAPA, Deviations and Change Controls. 
  • Oversees the Quality Agreement program working with the appreciate groups ensuring agreements are in place 

 

Qualifications

The ideal candidate will have:

  • Bachelorís degree in the life sciences
  • 8 to 10 years of experience in the medical device and/or pharmaceutical industries working in a Quality Assurance/Quality Compliance role 
  • Demonstrated people leadership skills. Significant experience and success track record of line and cross-functional team management or project management.
  • Bachelorís degree in the life sciences
  • Ability to work collaboratively within project teams to attain team goals.
  • Demonstrate strong organizational and interpersonal skills, building relationships with effective communication, influencing, conflict resolution, critical thinking and problem solving with a keen attention to detail. 

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