Associate Director/Senior Manager, Clinical (GCP) Quality Assurance Audit - 635
We are looking for an experienced Senior Clinical Quality Assurance (GCP) Auditor for an exciting small pharmaceutical company located in Central New Jersey. The title of this position is flexible (Associate Director or Senior Manager) commensurate with experience.
Please note this position is for a GCP Auditor of clinical trials. We are NOT looking for GMP or GLP auditors from manufacturing or labs.
This person will help establish the Clinical Quality Assurance function in a small pharma atmosphere, therefore, should be confident, independent and able to work well under minimal supervision. They should be hands-on and interested in working in a dynamic, entrepreneurial atmosphere with a broad scope of responsibility including conducting internal and external GCP audits of sites, CROs and documents. This person will also be involved in the development of processes and SOPs.
1. Bachelor degree required
2. Minimum 5+ years of CQA experience in pharma, biotech or a CRO required (8-10+ years preferred)
3. External and Internal GCP Clinical Auditing Experience Required (audits of investigator sites, CROs and clinical documents)
4. Experience developing SOPs and processes
5. Site, CRO, and document audit experience GCP
6. Global experience
7. Able to travel approximately 1-2x / month
8. Present salary?
9. Salary expectation? (salary range: $120k to $175k)
10. Must be a US Citizen or Green Card holder.
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