Support the Clinical Quality Assurance function within Development and Research Operations with primary responsibility for managing non-conformance and change control systems and providing GCP guidance for day to day operations. Secondary responsibilities include supporting GCP training, conducting system, study, site and vendor audits.
• Maintain effective strategies, systems and procedures, ensuring compliance with applicable GCP standards
• Support internal and regulatory inspections.
• Secure and utilize external consultant resources to ensure audits are completed on time and with excellence.
• Support audited groups in developing effective, risk based corrective actions.
• Authors/reviews summary reports, memos and standard operating procedures
• Partner with key customer groups in clinical Operations to develop and meet quality objectives.
• Develop and track key quality performance metrics to identify trends and mitigate emerging quality issues.
• Evaluates and improves existing processes with limited guidance
• Maintains on the job knowledge and skills by participating in applicable training
Key Relationships: Internal and external customers/sites and consultants.
• Minimum BS/BA in related field
• Working knowledge of GCP regulations/ guidelines (ICH, US FDA, ISO)
• Clinical Research Certification strongly desired
• Strong computer skills
• Excellent communication (verbal and written) skills and ability to work effectively on teams..
• Excellent organization skills
Experience may include:
Minimum 5 years’ experience in related healthcare, medical device or pharmaceutical industry