Responsibilities
- Plan, execute, and report routine or directed GCP audits using a risk-based approach or as directed by Quality Leadership.
- Maintain thorough knowledge of clinical research regulations and ICH GCP principles.
- Lead or assist with audit activities including investigator site, key document, and sponsor audits.
- Manage audit activities from planning through closure based on experience and regulatory understanding.
- Provide guidance to internal teams on SOP and regulatory requirements.
- Support or facilitate sponsor or CRO audits of company sites, either onsite or remotely, and report outcomes.
- Work within the Quality function to enhance overall quality across the organization.
- Assist in creating, reviewing, revising, and managing procedural documents.
- Identify and escalate issues, complaints, and non-conformances.
- Evaluate internal compliance with procedures, policies, programs, GCP, and applicable regulations.
- Support CAPA processes, investigations, non-conformances, inspections, and external audits.
- May lead less complex CAPA investigations as needed.
- Assist with oversight of contract auditor assignments when assigned.
- Perform other duties as assigned.
Requirements
- Bachelor's degree in a scientific or healthcare-related field from an accredited institution.
- At least 3 years of experience as a GCP Auditor in clinical quality assurance.
- Experience conducting GCP clinical investigator site and vendor audits.
- Excellent interpersonal, verbal and written communication, and collaboration skills with senior management, peers, sponsors, CROs, and clinical sites.
- Comprehensive knowledge of GCPs and relevant national and international clinical trial regulations.
- Integrity, commitment to quality, flexibility, critical thinking, and creativity.
- Ability to recognize and manage confidential information appropriately.
- Ability to work independently or in a team to plan, organize, prioritize, and follow up on multiple tasks and deliverables.
- Ability to lead or support sponsor audits and regulatory inspections.
- Detail-oriented while maintaining a big-picture perspective.
- Practical ability to apply proactive quality approaches in clinical trials.
- Proficient in Microsoft Office applications including Word, Excel, PowerPoint, and Teams.
- Ability to work with clinical study or quality electronic systems such as QMS, EDC, electronic source, and e-regulatory.
- Willingness to travel up to 20% for audits, meetings, presentations, and conferences.
Nice to Have
- Experience with internal audits is a plus.
- Experience using Excel for data trend identification and chart creation is preferred.
- Certification such as SQA RQAP-GCP or ASQ Certified Quality Auditor is encouraged but not required.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Paid time off
- Company holidays
- 401(k) retirement plan with company match
- Annual incentive program
Other
Travel: Up to 20% travel, as needed, for audits, project team meetings, client presentations and other professional meetings/conferences as needed.
