Senior Auditor, Quality Assurance - GCP

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

Job summary

An established industry player in the biopharmaceutical sector is seeking a GCP Quality Assurance Sr. Auditor to join their dynamic team. This role focuses on ensuring compliance with regulatory standards and conducting comprehensive audits across clinical trials. The ideal candidate will possess extensive experience in GCP and quality assurance, working closely with cross-functional teams and external partners. This position offers a unique opportunity to contribute to quality management systems and support clinical operations in a rapidly growing company specializing in neurology and psychiatry therapies. If you're passionate about quality assurance and compliance in the pharmaceutical industry, this is the perfect opportunity for you.

Qualifications

• 5+ years of pharmaceutical experience with a strong GCP background.
• Experience with internal and external audits in clinical settings.

Responsibilities

• Plan and conduct global clinical process and vendor audits.
• Develop audit reports and manage clinical vendor non-conformances.

Skills

GCP Compliance

Quality Assurance Auditing

Regulatory Knowledge

Clinical Operations

Risk Management

Education

BS degree in scientific, health care or related discipline

Tools

Clinical Trial Management Systems (CTMS)

Electronic Data Capture (EDC)

Job description

Overview

• The GCP Quality Assurance Sr. Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company’s compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day to day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials.
• The Sr. Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience.
• This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance

Responsibilities

• Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials.
• Plan and conduct audits of specific clinical processes based on risk.
• Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor.
• Develop audit reports and distribute them to appropriate stakeholders.
• Own and manage related clinical vendor non-conformances.
• Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.).
• Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors.
• Support the preparation, coordination, and participation of regulatory agency inspections.
• Participate in and support quality improvement projects.

Qualifications

• 5+ years of pharmaceutical experience
• BS degree in scientific, health care or related discipline
• Intensive GCP and safety background
• Experience with both internal and external process and systems audits
• Strong knowledge of development policies, procedures and standards (SOPs, QMS)
• Ability to work with global clinical teams in developing objectives for audits of clinical studies
• 10% Traveling required