Senior GCP Auditor (Good Clinical Practice Quality Assurance)

Job Summary

This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company's compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment.

Company Information

The opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site.

Audits

• Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance

Qualifications

• Bachelor's degree in a scientific, health care, or related discipline
• Minimum 5+ years of experience in the pharmaceutical industry
• Extensive GCP experience
• Proven experience conducting and managing internal and external GXP audits, including clinical development and safety/pharmacovigilance audits
• GCP guidelines and global regulatory requirements (e.g., FDA, EMA, ICH GCP)
• Familiarity with Quality Management Systems (QMS), SOPs, and compliance documentation

Experience

• Prior experience in a biopharmaceutical company focused on neurology or psychiatry therapies is a plus
• Extensive experience conducting and managing internal and external GXP audits, including clinical development and safety/pharmacovigilance audits
• Experience auditing CROs, CMOs, investigator sites, and clinical vendors
• Experience with clinical systems such as IRT and EDC from an audit perspective

Location

• Willingness and ability to work on-site in Paramus, NJ, three days per week (Tuesday, Wednesday, Thursday)
• Flexibility to adjust to potential changes in the hybrid schedule
• Availability for up to 10% travel

Skills

• Excellent communication, reporting, and stakeholder management