Senior Auditor, Quality Assurance - GCP

SK Life Science; Paramus (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player in the biopharmaceutical sector is seeking a Senior Auditor for Quality Assurance. This pivotal role focuses on ensuring compliance with GXP regulations and implementing quality management systems. The ideal candidate will leverage extensive experience in GCP, conducting internal and external audits while collaborating with cross-functional teams. This position offers an opportunity to contribute to innovative therapies in Neurology and Psychiatry, with a commitment to maintaining the highest standards in clinical development. Join a dynamic team dedicated to enhancing patient outcomes through rigorous quality assurance practices.

Qualifications

• 5+ years of experience in pharmaceutical quality assurance.
• Strong background in GCP and safety regulations.

Responsibilities

• Plan and conduct global clinical audits across trials.
• Manage clinical vendor non-conformances and support inspections.

Skills

GCP Compliance

Risk Management

Audit Management

Regulatory Knowledge

Education

Bachelor's in Scientific Discipline

Job description

Senior Auditor, Quality Assurance - GCP

Job Locations: US-NJ-Paramus

Overview

The GCP Quality Assurance Sr. Auditor reports to the Director of GCP/PVG Quality Assurance. This role focuses on ensuring GXP compliance with regulatory authorities, implementing the company's compliance directives, and supporting quality management systems to minimize risks in a regulated pharmaceutical environment. The incumbent will conduct internal and external GXP audits, providing support to clinical operations, non-clinical, and manufacturing teams, managing CROs, CMOs, investigator sites, and vendors involved in clinical trials.

The Sr. Auditor collaborates with QA and cross-functional teams, communicates with QA consultants, and interacts with external auditees, vendors, partners, and affiliates. The ideal candidate will have extensive GCP experience.

This position is with a rapidly growing biopharmaceutical company specializing in Neurology and Psychiatry therapies, based in Northern New Jersey, requiring on-site presence. Responsibilities include managing all types of audits within the Clinical Development and Safety Pharmacovigilance programs.

Responsibilities

1. Plan and conduct global clinical process and vendor audits across all clinical trials.
2. Perform risk-based audits of specific clinical processes.
3. Audit clinical vendors alongside SMEs (IRT, EDC, etc.) to assess services.
4. Develop and distribute audit reports to stakeholders.
5. Manage clinical vendor non-conformances.
6. Review and audit clinical regulations and guidelines (e.g., FDA regulations, GCP).
7. Collaborate with sourcing, quality, and clinical teams to manage vendors.
8. Support regulatory inspections.
9. Participate in quality improvement projects.

Qualifications

1. 5+ years of pharmaceutical experience.
2. BSc in a scientific, healthcare, or related discipline.
3. Strong GCP and safety background.
4. Experience with internal and external audits.
5. Knowledge of development policies, SOPs, and QMS.
6. Ability to work with global clinical teams and develop audit objectives.
7. Willingness to travel up to 10%.