Description
As a member of the Quality team, this position provides GCP (Good Clinical Practice) oversight and QA support to the Clinical team. Other areas of responsibilities include, but are not limited to the following: Manage the GCP audit program by ensuring appropriate plan, schedule, conduct and report of audits, coordination of audit follow-up including CAPA and corrective action; may develop and implement GCP training.Responsibilities:
- Partner with the Clinical Department to help assure that all clinical trials are assessed for compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
- Manage schedules, site visits and audits of clinical research organizations (CROs) to assure compliance with all applicable regulations and standards.
- Collaborate with Clinical stakeholders, including but not limited to, Medical Affairs personnel, study teams and investigative sites. Provide guidance and feedback on regulations and quality best practices
- Coordinate, develop, maintain, and/or deliver GCP training programs.
- Perform internal audits and report to management significant compliance risks in the GCP area including periodic metrics, analysis and interpretation of audit findings. Provide recommendation to mitigate risks as appropriate.
- Operate within the limits of approved quality agreements with CROs.
Qualifications:
- BS/BA degree in a scientific or health-rated field with 5+ years of progressive experience in the Pharmaceutical and/or Biotechnology industry with at least 1 years' quality GCP experience at the manager level. For the Senior Manager, 8+ years relevant QA experience and 3+ years GCP experience.
- Knowledge of applicable FDA, EU and ICH regulatory requirements for GCP.
- Proven experience in clinical compliance and/or clinical quality assurance.
- Experience in managing and conducting compliance audits including leading internal process audits is required.
To find out more about Real please visit www.realstaffing.com