Quality Lead

A Few Words About Us

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

1. To work with and on behalf of CTPQ/GCP Compliance Management within DevOps, performing management of Significant Quality Events.
2. Significant Quality Event Lead: responsible for 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.
3. Conduct broader impacts across the portfolio to share learnings with other impacted study teams.
4. Interact with a diverse range of stakeholders from varying internal lines.
5. Be an effective project manager, leading Significant Quality Event Teams and/or Investigation/RCA Teams, and progressing delivery of actions.
6. Understand and have knowledge of GCP, clinical trial processes and systems, CAPA, quality issues, regulatory requirements, quality management, Root Cause Analysis, and inspection readiness.
7. Manage Significant Quality Events and form the Significant Quality Event Team.
8. Arrange meetings with the Significant Quality Event Team, RCA Team, and/or Business Process Owner within specified timelines.
9. Document meeting outcomes in meeting minutes or other formats.
10. Facilitate Root Cause Analysis (or other types of investigation) and produce outputs.
11. Ensure appropriate actions are assigned and progressed to completion.
12. Update the appropriate database and ensure all documentation is filed appropriately.

Qualifications

1. Degree in one of the disciplines related to drug development or business.
2. 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.
3. Knowledge of clinical trials operational processes and systems, which may include study management, data management, reporting, and project management.
4. Understanding of clinical trials.
5. Ability to work successfully with internal and external partners; strong interpersonal skills and ability to build and maintain excellent working relationships across lines in a matrix organization.
6. Experience leading global initiatives or project teams, with appreciation for diverse regulatory requirements of different sites and countries.
7. Knowledge of quality requirements across a range of different countries.
8. Strong influencing skills with the ability to influence a broad range of global stakeholders.
9. Excellent communication skills adaptable to meet the needs of diverse stakeholder groups, both internal and external.
10. Record of achievement and delivery for personal and team goals.
11. Ability to balance and prioritize a diverse and demanding workload.
12. Works independently and proactively sets own work agenda with minimum guidance.
13. Familiarity with ICH GCP and regulatory obligations.
14. Quality and compliance management, QC.
15. Project/initiative coordination and management skills.
16. CI/RCA skill and experience.
17. Knowledge of ICH GCP and regulations to assess GCP situations and appropriate actions.
18. Ability to lead cross-line global initiatives or root cause analysis for quality-related process improvement.