- Partner cross-functionally to support the successful and compliance execution of clinical trials
- Contribute to the development of the GCP audit plan
- Conduct and/or oversee the conduct of audits of clinical investigator sites, internal GCP systems and processes, external vendors and clinical trial documents
- Identify and report systemic issues and improvement opportunities with the assistance of management/senior auditor, as necessary
- Independently perform audits, including preparation, conduct, presentation and reporting
- Assist in assessing proposed CAPA plans
- Support GCP Regulatory Authority inspections
- Contribute to the continued development of a quality culture
Requirments:
- BS/BA preferably in life sciences or STEM disciplines
- Required minimum of 5 years of related experience in biotech, pharmaceutical or related industry
- Working knowledge of FDA, EMA, ICH GCP guidelines and GCP regulations (e.g., ICH E6 (R3)
- Experience working with CROs and vendors
- Experience planning, conducting and reporting all types of GCP audits (e.g., investigator sties, processes, vendors)
Knowledge, Skills and Abilities:
- Identify GCP non-compliance and communicate significant audit findings to auditees in a professional and factual manner
- Effectively manage multiple projects in a fast-paced environment
- Collaborate and negotiate effectively in a dynamic, cross-functional environment
- Work independently and within a team environment
- Strong written and verbal communication and presentation skills
#INDZH
Pay: $70.00 - $93.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
Education:
Experience:
- GCP QA Management: 5 years (Required)
- FDA, EMA, ICH GCP guidelines and regulations: 5 years (Required)
Work Location: Remote
