MD
Senior GCP Auditor (Good Clinical Practice Quality Assurance)
Macpower Digital Assets Edge Private Limited
🇺🇸 United States
Hybrid
Senior
5 days ago
$48 – $53 / hour
- GxP
- GCP
- ICH-GCP
- CMOS
5 days ago
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. This 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. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance
Must Have:
- Bachelor's degree in a scientific, health care, or related discipline.
- Minimum 5+ years of experience in the pharmaceutical industry
- The ideal candidate will have 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).
- auditing CROs, CMOs, investigator sites, and clinical vendors.
- clinical systems such as IRT and EDC from an audit perspective.
- Familiarity with Quality Management Systems (QMS), SOPs, and compliance documentation.
Nice to Have:
- Prior experience in a biopharmaceutical company focused on neurology or psychiatry therapies.
Additional information:
- 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.
- Excellent communication, reporting, and stakeholder management.
Senior GCP Auditor (Good Clinical Practice Quality Assurance) · Macpower Digital Assets Edge Private Limited