about 2 months ago
The Senior Manager, GCP Quality will provide quality and compliance support and will be responsible for creating and leading quality plans to include external GCP audits of clinical services providers, CROs, suppliers, and investigator sites, as well as internal audit of clinical processes and procedures. The position will be responsible for supporting the risk-based GCP audit programs and compliance oversight.
Abilities and responsibilities:
- Responsible for implementing standards, policies, and procedures for GCP regulatory compliance
- Prepares GCP compliance strategy and advise on studies or programs
- Develops audit strategy for assigned programs or studies
- Organizes and directs runs GCP compliance audits (US and international), including clinical investigator sites, contract clinical laboratories and CROs to identify compliance risks and determine compliance status
- Supports the assessment of GCP compliance risk areas and implements risk mitigation measures
- Reports audit findings to management with recommendations for resolution and verifies appropriate corrective actions have been executed and recorded
- Performs QA reviews of project‐related clinical study documents
- Supports inspection readiness efforts
- BS/BA degree in scientific discipline. Advanced degree preferred
- 6-8 years of experience in GCP Quality Assurance.
- Experience with all phases of clinical trials
- Strong knowledge of Good Clinical Practices (FDA and ICH)