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GCP Sr. Auditor Job Opening In Paramus – Now Hiring San R&D Business Solutions LLC


Job description

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

Required Skill Profession

Healthcare Practitioners And Technical


  • Job Details

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Unlock Your GCP Sr Potential: Insight & Career Growth Guide


Real-time GCP Sr Jobs Trends (Graphical Representation)

Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph here. Uncover the dynamic job market trends for GCP Sr in Paramus, United States, highlighting market share and opportunities for professionals in GCP Sr roles.

53443 Jobs in United States
53443
20 Jobs in Paramus
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Are You Looking for GCP Sr. Auditor Job?

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The Work Culture

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:

1. Independence

2. Loyalty

3. Impartiapty

4. Integrity

5. Accountabipty

6. Respect for human rights

7. Obeying United States laws and regulations

What Is the Average Salary Range for GCP Sr. Auditor Positions?

The average salary range for a 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.

What Are the Key Qualifications for GCP Sr. Auditor?

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. The generic skills are mostly outlined by the . Be sure to check the specific job listing for detailed requirements and qualifications.

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Interview Tips for GCP Sr. Auditor Job Success

San R&D Business Solutions LLC interview tips for GCP Sr. Auditor

Here are some tips to help you prepare for and ace your GCP Sr. Auditor job interview:

Before the Interview:

Research: Learn about the San R&D Business Solutions LLC's mission, values, products, and the specific job requirements and get further information about

Other Openings

Practice: Prepare answers to common interview questions and rehearse using the STAR method (Situation, Task, Action, Result) to showcase your skills and experiences.

Dress Professionally: Choose attire appropriate for the company culture.

Prepare Questions: Show your interest by having thoughtful questions for the interviewer.

Plan Your Commute: Allow ample time to arrive on time and avoid feeling rushed.

During the Interview:

Be Punctual: Arrive on time to demonstrate professionalism and respect.

Make a Great First Impression: Greet the interviewer with a handshake, smile, and eye contact.

Confidence and Enthusiasm: Project a positive attitude and show your genuine interest in the opportunity.

Answer Thoughtfully: Listen carefully, take a moment to formulate clear and concise responses. Highlight relevant skills and experiences using the STAR method.

Ask Prepared Questions: Demonstrate curiosity and engagement with the role and company.

Follow Up: Send a thank-you email to the interviewer within 24 hours.

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Be Yourself: Let your personality shine through while maintaining professionalism.

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Body Language: Maintain good posture, avoid fidgeting, and make eye contact.

Turn Off Phone: Avoid distractions during the interview.

Final Thought:

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.

By following these tips, you can increase your chances of making a positive impression and landing the job!

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