Senior QA Auditor - GCP Audits
Company: Provident Behavioral Health
- Location: Indianapolis, United States
- Seniority: Senior
- Employment type: Full-time
- Posted: 9 days ago
- Offer language: English
Job description
Overview
This role involves independently planning and conducting clinical (GCP) audits to ensure compliance with regulations, guidelines, and SOPs. Responsibilities include preparing audit reports, providing regulatory interpretation, supporting management in compliance assessment, and collaborating with global teams to enhance quality and continuous improvement.
Core Duties
- Conduct audits across multiple countries, evaluate findings, and report to stakeholders.
- Offer guidance on regulations, policies, and corrective action plans.
- Review investigations, root cause analyses, CAPA, and effectiveness checks.
- Maintain electronic quality management systems and support QA initiatives.
- Perform pre-inspection site visits and support process improvements.
Additional Tasks
Assist in training staff, manage quality issues, host audits and inspections, and provide educational guidance on compliance procedures.
Qualifications
- Experience in clinical trial investigator site audits and GCP.
- Minimum 5 years in pharmaceutical or related fields, with 3+ years in QA audits.
- Strong knowledge of R&D processes, regulations, and QA procedures.
- Excellent interpersonal, problem-solving, and organizational skills.
- Proficiency with MS Office applications.
Preferred Skills: Clinical study report/data management audits and a bachelor’s degree are advantageous.
Key Benefits
Opportunity to lead audit lifecycle, work within a global organization, collaborate with diverse teams, and contribute to quality and compliance initiatives.
