GCP Auditor

Job Title:

GCP Auditor/Senior Auditor, Quality Assurance Job Description

This position focuses on ensuring GXP compliance with regulatory authorities, driving and implementing compliance directives, and supporting quality management systems to minimize risks in a regulated pharmaceutical environment. The role involves conducting and participating in all GXP QA audit programs, including internal and external audits, and providing support to the GXP QA Director across clinical operations, non-clinical, and manufacturing sectors.

• Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials.
• Plan and conduct audits of specific clinical processes based on risk.
• Perform clinical vendor audits along with various subject matter experts to comprehensively assess all services provided by a vendor.
• Develop audit reports and distribute them to appropriate stakeholders.
• Own and manage related clinical vendor non-conformances.
• Review, understand, and audit clinical-related regulations and guidelines (., FDA regulations, GCP, .
• Collaborate with clinical sourcing, supplier quality, and clinical partnership to manage clinical vendors.
• Support the preparation, coordination, and participation of regulatory agency inspections.
• Participate in and support quality improvement projects.

• 5+ years of pharmaceutical experience.
• Bachelor's degree in scientific, healthcare, or related discipline.
• Extensive GCP and safety background.
• Experience with both internal and external process and systems audits.
• Strong knowledge of development policies, procedures, and standards (SOPs, QMS).
• Ability to work with global clinical teams in developing objectives for audits of clinical studies.

• Sponsor experience, not only CRO experience.
• 2 years of experience with GCP, TMF audits, system audits, inspection readiness, and CRO audits.
• 2 years of experience in independent auditing.
• Desirable:
  Master trial with phase 2 and 3 experience.

This opportunity is with a rapidly growing biopharmaceutical company specializing in Neurology and Psychiatry therapies, based in Northern New Jersey. The role requires a minimum of three days in-office, from Tuesday to Thursday. The team currently consists of four people, including one GCP auditor and one PV auditor, with additional support from an auditor based in Korea.

This is a Contract to Hire position based out of Paramus, NJ.

The pay range for this position is $60.00 - $60.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Paramus,NJ.

This position is anticipated to close on Feb 27, 2026.