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Job Description
GCP Senior Auditor
Paramus, NJ (Hybrid) Contract Mid-Senior Level
Ensure GxP compliance, quality oversight, and audit excellence for a fast-growing biopharmaceutical company advancing neurology and psychiatry therapies.
A rapidly growing biopharmaceutical organization is seeking an experienced GCP Senior Auditor to support Quality Assurance programs across global clinical development and safety operations. This role is ideal for a QA professional with deep GCP expertise and a strong understanding of pharmaceutical regulations, vendor oversight, and quality management systems.
This is a hybrid position based in Paramus, NJ , requiring regular onsite presence.
Position Overview The GCP Senior Auditor plays a key role in ensuring compliance with regulatory requirements, internal SOPs, and quality standards across clinical research and pharmacovigilance functions. Reporting to the Director of GCP / PVG Quality Assurance, this position will plan and execute internal and external audits, oversee vendor compliance, and contribute to continuous improvement initiatives within the company's GxP Quality System.
Key Responsibilities
Plan and conduct global clinical process and vendor audits across all clinical trials.
Perform risk-based audits of specific GCP processes and systems.
Collaborate with SMEs (e.g., IRT, EDC) to assess vendor performance and compliance.
Develop and deliver detailed audit reports and track CAPAs and non-conformances.
Ensure adherence to FDA, ICH GCP, and other global regulatory guidelines.
Support the preparation and coordination of regulatory agency inspections.
Partner with cross-functional teams in Clinical Operations, Pharmacovigilance, and Manufacturing to strengthen audit readiness.
Participate in quality improvement projects and contribute to SOP and QMS enhancements.
Required Qualifications
Bachelor's degree in a scientific, healthcare, or related discipline.
5+ years of pharmaceutical industry experience with a focus on GCP auditing.
Demonstrated expertise in clinical and vendor audit management.
Strong understanding of GxP compliance, SOPs, and QMS frameworks.
Proven ability to lead audits independently and collaborate across global teams.
Excellent knowledge of FDA regulations, ICH-GCP, and related standards.
Ability to travel up to 10% domestically and internationally.
Preferred Experience & Skills
Experience supporting regulatory inspections and audit CAPA processes.
Knowledge of Safety / Pharmacovigilance and Clinical Development operations.
Strong written and verbal communication skills with executive-level presence.
Ability to manage multiple audits and priorities in a fast-paced environment.
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GCP Senior Auditor
Paramus, NJ (Hybrid) Contract Mid-Senior Level
Ensure GxP compliance, quality oversight, and audit excellence for a fast-growing biopharmaceutical company advancing neurology and psychiatry therapies.
A rapidly growing biopharmaceutical organization is seeking an experienced GCP Senior Auditor to support Quality Assurance programs across global clinical development and safety operations. This role is ideal for a QA professional with deep GCP expertise and a strong understanding of pharmaceutical regulations, vendor oversight, and quality management systems.
This is a hybrid position based in Paramus, NJ , requiring regular onsite presence.
Position Overview The GCP Senior Auditor plays a key role in ensuring compliance with regulatory requirements, internal SOPs, and quality standards across clinical research and pharmacovigilance functions. Reporting to the Director of GCP / PVG Quality Assurance, this position will plan and execute internal and external audits, oversee vendor compliance, and contribute to continuous improvement initiatives within the company's GxP Quality System.
Key Responsibilities
Plan and conduct global clinical process and vendor audits across all clinical trials.
Perform risk-based audits of specific GCP processes and systems.
Collaborate with SMEs (e.g., IRT, EDC) to assess vendor performance and compliance.
Develop and deliver detailed audit reports and track CAPAs and non-conformances.
Ensure adherence to FDA, ICH GCP, and other global regulatory guidelines.
Support the preparation and coordination of regulatory agency inspections.
Partner with cross-functional teams in Clinical Operations, Pharmacovigilance, and Manufacturing to strengthen audit readiness.
Participate in quality improvement projects and contribute to SOP and QMS enhancements.
Required Qualifications
Bachelor's degree in a scientific, healthcare, or related discipline.
5+ years of pharmaceutical industry experience with a focus on GCP auditing.
Demonstrated expertise in clinical and vendor audit management.
Strong understanding of GxP compliance, SOPs, and QMS frameworks.
Proven ability to lead audits independently and collaborate across global teams.
Excellent knowledge of FDA regulations, ICH-GCP, and related standards.
Ability to travel up to 10% domestically and internationally.
Preferred Experience & Skills
Experience supporting regulatory inspections and audit CAPA processes.
Knowledge of Safety / Pharmacovigilance and Clinical Development operations.
Strong written and verbal communication skills with executive-level presence.
Ability to manage multiple audits and priorities in a fast-paced environment.
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