Senior GCP QA Auditor — On-Site in NJ, Drive Compliance

5 Star Recruitment; Paramus (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading biopharmaceutical company in New Jersey is seeking a GCP Quality Assurance Sr. Auditor. This position will ensure GXP compliance with regulatory authorities and manage audits for clinical development and pharmacovigilance. Candidates must have a Bachelor's degree and a minimum of 5 years of pharmaceutical industry experience. The ideal candidate will have extensive GCP audit experience. This role requires on-site presence in Paramus, NJ, and offers an opportunity to contribute to a rapidly growing organization focused on neurology and psychiatry therapies.

Qualifications

• Minimum 5+ years of experience in the pharmaceutical industry.
• Proven experience conducting and managing internal and external GXP audits, including clinical development and safety audits.
• Familiarity with auditing CROs, CMOs, investigator sites, and clinical vendors.

Responsibilities

• Plan and conduct scheduled global clinical process and clinical vendor audits.
• Develop audit reports and distribute them to stakeholders.
• Support the preparation for regulatory agency inspections.

Skills

GCP experience

Internal and external GXP audits

Clinical vendor audits

Collaboration with cross-functional teams

Education

Bachelor's degree in a scientific or health care discipline

Tools

IRT systems

EDC systems

Quality Management Systems (QMS)

Job description

A leading biopharmaceutical company in New Jersey is seeking a GCP Quality Assurance Sr. Auditor. This position will ensure GXP compliance with regulatory authorities and manage audits for clinical development and pharmacovigilance. Candidates must have a Bachelor's degree and a minimum of 5 years of pharmaceutical industry experience. The ideal candidate will have extensive GCP audit experience. This role requires on-site presence in Paramus, NJ, and offers an opportunity to contribute to a rapidly growing organization focused on neurology and psychiatry therapies.