Sr. Quality Assurance Consultant
- Provide development, implementation, and oversight of quality activities in support of GLP activities
- Qualify and monitor GLP Vendors and oversight of internal GLP activities
- Plan, track and oversee GCP audits of external contract laboratories and contract research organizations.
- Understand the principles and application of quality and regulatory compliance related to GLP regulated activities
- Ensure that no deviations from approved protocols have been made without proper authorization and documentation.
- Bachelor's Degree (BA/BS), preferably life science with 8 years' experience in GCP Quality Systems that support pharmaceutical development.
- 10+ years' experience in a staff leadership role, demonstrating strong leadership skills of staff and peers.
- Expertise in GCP regulations and guidance for FDA and International agencies