GCP Senior Auditor

4 days ago

Paramus, United States Scimaxconsulting Full time

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.

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