Senior Auditor, Quality Assurance - GCP

SK Life Science, Inc.; Paramus (NJ); On-site; USD 80,000 - 140,000; Full time

Job summary

An established industry player is seeking a Senior Auditor in Quality Assurance to ensure GXP compliance within a regulated pharmaceutical environment. This role involves conducting internal and external audits, supporting clinical operations, and managing vendor relationships to uphold the highest quality standards. The ideal candidate will have extensive GCP experience and a strong background in quality management systems. Join a rapidly growing biopharmaceutical company specializing in Neurology and Psychiatry therapies, where your expertise will contribute to critical clinical trials and compliance efforts. This is a fantastic opportunity to make a significant impact in a dynamic team.

Qualifications

• 5+ years of pharmaceutical experience required.
• Intensive GCP and safety background essential.

Responsibilities

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

Skills

GCP Compliance

Quality Management Systems

Audit Programs

Regulatory Knowledge

Clinical Operations

Education

BS in Scientific Discipline

Job description

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• 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
  
  

• 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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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