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.