Ecocareers · 1 week ago
GCP Auditor, Quality Assurance
Hackensack, NJ
Full-time
Onsite
Entry, Mid Level
2+ years expEcocareers is a rapidly growing biopharmaceutical company specializing in Neurology and Psychiatry therapies. The GCP Quality Assurance Auditor is responsible for ensuring GxP compliance with regulatory authorities, implementing compliance directives, and supporting 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