GCP Senior Auditor

Join a rapidly growing biopharmaceutical company specializing in Neurology and Psychiatry therapies . As a GCP Senior Auditor , you will play a key role in ensuring GXP compliance with global regulatory authorities, driving company-wide compliance initiatives, and strengthening quality management systems to minimize risk in a regulated environment.

This role is ideal for a detail-oriented professional with strong Good Clinical Practice (GCP) experience and a passion for maintaining high-quality standards across global clinical operations.

Key Responsibilities

Audit Leadership & Compliance Oversight

• Plan, conduct, and manage global clinical process and vendor audits across multiple trials.
• Execute internal and external GXP audits, ensuring adherence to FDA, EMA, and ICH GCP guidelines.
• Collaborate with clinical sourcing, supplier quality, and clinical partnerships to evaluate and manage CROs, CMOs, investigator sites, and other vendors.
• Audit clinical systems (IRT, EDC, etc.) with relevant subject matter experts.

Quality Management & Risk Mitigation

• Develop detailed audit reports and manage related non-conformance items.
• Ensure alignment with corporate Quality Management Systems (QMS) and Standard Operating Procedures (SOPs).
• Support regulatory inspections by preparing documentation and participating in audit readiness activities.
• Participate in quality improvement initiatives across Clinical Development and Safety/Pharmacovigilance functions.

Required Qualifications

• Bachelor's degree in a scientific, healthcare, or related discipline .
• Minimum 5+ years of experience in the pharmaceutical or biopharmaceutical industry.
• Strong background in GCP auditing and safety/pharmacovigilance .
• Demonstrated experience conducting and managing internal and external GXP audits .
• Proven knowledge of FDA, EMA, and ICH GCP regulatory requirements .
• Familiarity with QMS, SOPs, and compliance documentation .
• Experience auditing CROs, CMOs, investigator sites , and clinical vendors.
• Proficiency in auditing clinical systems such as IRT and EDC.

Preferred Qualifications

• Experience within a biopharmaceutical organization focused on neurology or psychiatry therapeutic areas.
• Strong communication and stakeholder engagement skills.

Additional Details

• Hybrid schedule: 3 days on-site (Tuesday-Thursday) in Paramus, NJ.
• Flexibility is required as the on-site schedule may adjust over time.
• Up to 10% travel may be required for audits and inspections.