28 days ago
Associate Director/Director, Quality Assurance GCP Lead
My client is a small molecule oncology focused biotech looking for someone to help lead their US quality assurance team. The client is located in Maryland but exceptional candidates will be considered for fully remote out of state.
- Function as QA GCP Lead for assigned projects
- Have thorough knowledge of GCP, EU Directives, ICH, and are familiar with current and emerging US and global guidelines and regulations and apply in the company’s clinical studies for the development of quality risk mitigation strategies.
- Lead and provide overall quality assurance strategies for clinical development.
- Perform risk assessments to identify audit targets, establish audit plan, conduct internal, investigational site and vendor audits, develop and maintain audit tools, checklists, and author audit reports and other audit-related documentation.
- Ensures timely communication of QA issues including critical audit findings, potential misconduct or issues of significant deviation to stakeholders and management.
- Work with relevant function for CAPA plan. Define and implement the health authority inspection strategies in support of regulatory submissions and GCP compliance.
- Author or review QA SOPs and conduct trainings across functions.
- BS in Sciences required; advanced degree highly preferred
- Must have 8+ years of pharmaceutical or biotech industry experience
- Must have 6+ years of hands-on quality assurance lead experience, with GCP focus
- 3+ years of clinical trial monitoring and/or pharmacovigilance experience.
- Experience in leading internal, investigational site and vendor audit is essential
- Experience in leading FDA and other health authorities’ inspection is a must