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Urgent! GCP Sr. Auditor Job Opening In Paramus – Now Hiring San R&D Business Solutions LLC
Job Title: GCP Sr. Auditor Work Location: Paramus, NJ Contract Type: W2 Only Work Type: Hybrid (3 days/week at Office) Travel Required: Upto ~10% site travel Work Authorization: Only GC / US Citizens About the Role: As the GCP Quality Assurance Senior Auditor, you will play a critical role in ensuring compliance with global GxP regulations, managing audits across clinical, nonclinical, and pharmacovigilance (PV) domains, and supporting high-integrity quality systems.
You will report to the Director of GCP/PV Quality Assurance and will partner closely with clinical operations, vendor management, and cross-functional QA teams.
Key Responsibilities: Plan and lead internal and external GxP audits (clinical trials, vendor/CRO audits, investigator sites, CMOs, etc.) Conduct risk-based audits of clinical processes and vendor systems (e.g. IRT, EDC) Prepare detailed audit reports, issue non-conformances, and follow through on corrective / preventive actions (CAPAs) Interface with stakeholders (vendors, partners, CROs, CMOs, investigators) to ensure audit findings are resolved effectively Support preparation for regulatory inspections and site audits Assist in quality improvement initiatives and continual enhancement of QA processes and practices Review and interpret clinical development and safety policies, SOPs, guidelines (e.g. ICH E6, GCP, applicable FDA/EMA regulations) Provide QA support to cross-functional teams involved in clinical operations, nonclinical, and safety/PV Maintain audit schedules, metrics, and quality documentation May mentor junior QA auditors and act as a subject matter resource Required Skills & Qualifications: (Must-Have) Bachelors degree in science, healthcare, life sciences, or related discipline Minimum 5+ years in pharmaceutical or biotech industry Strong experience in GCP audits (internal/external) and clinical quality assurance Familiarity auditing CROs, CMOs, investigator sites, and clinical vendors Knowledge of quality systems (QMS), SOPs, compliance documentation, CAPA processes Ability to audit clinical systems such as IRT, EDC, and other vendor systems Solid understanding of global regulatory guidelines (FDA, EMA, ICH GCP) Strong report writing, communication, and stakeholder management skills Up to 10% domestic/international travel Preferred Skills: (Nice-to-Have) Previous experience in neurology, psychiatry, or CNS therapeutic area Experience in pharmacovigilance / safety audits Certification in QA / auditing Physical & Work Conditions: Office environment, with occasional site or vendor visits Ability to travel as needed (10%) Must be comfortable working with and reviewing clinical and audit documentation On-site presence required for key audit and inspection events
5+ years
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Unlock Your GCP Sr Potential: Insight & Career Growth Guide
Real-time GCP Sr Jobs Trends in Paramus, United States (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for GCP Sr in Paramus, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 53448 jobs in United States and 20 jobs in Paramus. This comprehensive analysis highlights market share and opportunities for professionals in GCP Sr roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! San R&D Business Solutions LLC is currently hiring and seeking a GCP Sr. Auditor to join their team. Feel free to download the job details.
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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at San R&D Business Solutions LLC adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a GCP Sr. Auditor Jobs United States varies, but the pay scale is rated "Standard" in Paramus. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for GCP Sr. Auditor typically include Healthcare Practitioners And Technical and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Before the Interview:To prepare for your GCP Sr. Auditor interview at San R&D Business Solutions LLC, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the San R&D Business Solutions LLC's products or services and be prepared to discuss how you can contribute to their success.
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