Senior Quality Strategist

2 weeks ago


Groton, Connecticut, United States Integrated Resources Full time

Job Overview: Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. Our mission centers on delivering only the best quality talent, the first time and every time.

Estimated Salary: $120,000 - $180,000 per year

Job Description: To work with and on behalf of CTPQ/GCP Compliance Management within DevOps, performing management of Significant Quality Events.

Key Responsibilities:

  • Forming and leading the Significant Quality Event Team and coordinating all activities related to initiating immediate action, conducting Investigation/RCA, developing corrective and preventive actions as needed, and documenting case activities within the appropriate database.
  • Conduct broader impacts across the portfolio to share learnings with other impacted study teams.
  • Interact with a diverse range of stakeholders from varying internal lines.
  • Be an effective project manager, leading Significant Quality Event Teams and/or Investigation/RCA Teams, and progressing delivery of actions.
  • Understand and have knowledge of GCP, clinical trial processes and systems, CAPA, quality issues, regulatory requirements, quality management, Root Cause Analysis, and inspection readiness.

Qualifications: Degree in one of the disciplines related to drug development or business. Advanced/in-depth knowledge which may include quality audit, quality management, inspection readiness, quality and compliance assessments, CAPA Management, continuous improvement methodology, root cause analysis. Knowledge of clinical trials operational processes and systems, which may include study management, data management, reporting, and project management.


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