Ecocareers ยท 17 hours ago
GCP Auditor, Quality Assurance
Hackensack, NJ
Full-time
Onsite
Entry, Mid Level
2+ years expConfidential company is a rapidly growing biopharmaceutical company specializing in Neurology and Psychiatry therapies. They are seeking a GCP Quality Assurance Auditor to ensure GxP compliance with regulatory authorities and support quality management systems in a regulated pharmaceutical environment.
Staffing & Recruiting
Responsibilities
Plan and conduct global clinical process and vendor audits across clinical trials
Perform risk-based audits of specific clinical processes
Conduct clinical vendor audits with SMEs (e.g., IRT, EDC)
Develop and distribute audit reports to stakeholders
Own and manage clinical vendor non-conformances (CAPAs)
Review and audit compliance with FDA regulations, ICH-GCP, and related guidelines
Collaborate with clinical sourcing, supplier quality, and clinical partnerships
Support regulatory agency inspections
Participate in quality improvement initiatives
Qualification
Required
2+ years of pharmaceutical industry experience
Bachelor's degree in scientific, healthcare, or related discipline
Strong GCP and safety background
Experience with internal and external audits (process & systems)
Strong knowledge of SOPs, QMS, policies, and procedures
Ability to work with global clinical teams
10% travel required
Preferred
Extensive GCP auditing experience
Strong communication skills with internal teams and external partners
Detail-oriented with a risk-based auditing mindset
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase