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GCP Compliance Director

4 weeks ago

Orlando, United States RoKo Staffing Consulting, LLC Full time

GCP Compliance Director:

Permanent Job

Location: Orlando, FL


The GCP Compliance Director leads the company's Compliance Team, ensuring adherence to regulatory standards, data integrity, and clinical research compliance. Key responsibilities include managing quality assurance, regulatory affairs, and risk analyses, overseeing audits and inspections, ensuring inspection readiness, and maintaining SOPs and compliance documentation. The role also involves analyzing performance metrics, implementing process improvements, and providing regulatory guidance to leadership and staff.


Supervisory Duties

The position includes hiring, training, mentoring, and performance evaluation of team members, ensuring compliance with company policies and applicable laws.


Required Skills and Knowledge

  • Expertise in FDA inspections and industry audits.
  • Strong leadership, critical thinking, and communication skills.
  • Proven ability to create and implement compliance plans and drive process improvements.


Qualifications

  • Bachelor’s degree (Master’s preferred) in a related field.
  • Relevant certifications (e.g., CCRC, ACRP-CP) are strongly preferred.
  • At least three years of clinical research compliance experience and team management.


Experience

  • Extensive clinical trials background, including auditing and quality assurance roles.
  • Demonstrated success in compliance management and operational excellence.


Physical Requirements

Primarily desk work with prolonged computer use.


If you are interested in this opportunity, please apply jalexandrowicz@rokostaffing.org