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GCP Senior Auditor Job Opening In Paramus – Now Hiring Scimaxconsulting


Job description

Join a rapidly growing biopharmaceutical company specializing in Neurology and Psychiatry therapies.

As a GCP Senior Auditor, you will play a key role in ensuring GXP compliance with global regulatory authorities, driving company-wide compliance initiatives, and strengthening quality management systems to minimize risk in a regulated environment.

This role is ideal for a detail-oriented professional with strong Good Clinical Practice (GCP) experience and a passion for maintaining high-quality standards across global clinical operations.

Key Responsibilities

Audit Leadership & Compliance Oversight

  • Plan, conduct, and manage global clinical process and vendor audits across multiple trials.
  • Execute internal and external GXP audits, ensuring adherence to FDA, EMA, and ICH GCP guidelines.
  • Collaborate with clinical sourcing, supplier quality, and clinical partnerships to evaluate and manage CROs, CMOs, investigator sites, and other vendors.
  • Audit clinical systems (IRT, EDC, etc.) with relevant subject matter experts.

Quality Management & Risk Mitigation

  • Develop detailed audit reports and manage related non-conformance items.
  • Ensure alignment with corporate Quality Management Systems (QMS) and Standard Operating Procedures (SOPs).
  • Support regulatory inspections by preparing documentation and participating in audit readiness activities.
  • Participate in quality improvement initiatives across Clinical Development and Safety/Pharmacovigilance functions.

Required Qualifications

  • Bachelor's degree in a scientific, healthcare, or related discipline.
  • Minimum 5+ years of experience in the pharmaceutical or biopharmaceutical industry.
  • Strong background in GCP auditing and safety/pharmacovigilance.
  • Demonstrated experience conducting and managing internal and external GXP audits.
  • Proven knowledge of FDA, EMA, and ICH GCP regulatory requirements.
  • Familiarity with QMS, SOPs, and compliance documentation.
  • Experience auditing CROs, CMOs, investigator sites, and clinical vendors.
  • Proficiency in auditing clinical systems such as IRT and EDC.

Preferred Qualifications

  • Experience within a biopharmaceutical organization focused on neurology or psychiatry therapeutic areas.
  • Strong communication and stakeholder engagement skills.

Additional Details

  • Hybrid schedule: 3 days on-site (Tuesday-Thursday) in Paramus, NJ.
  • Flexibility is required as the on-site schedule may adjust over time.
  • Up to 10% travel may be required for audits and inspections.

Required Skill Profession

Other General


  • Job Details

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Unlock Your GCP Senior Potential: Insight & Career Growth Guide


Real-time GCP Senior 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 Senior in Paramus, United States, highlighting market share and opportunities for professionals in GCP Senior roles.

184797 Jobs in United States
184797
24 Jobs in Paramus
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Download Gcp Senior Jobs Trends in Paramus and United States

Are You Looking for GCP Senior Auditor Job?

Great news! is currently hiring and seeking a GCP Senior Auditor to join their team. Feel free to download the job details.

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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 Scimaxconsulting 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 Senior 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 Senior Auditor?

Key qualifications for GCP Senior Auditor typically include Other General 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 Senior Auditor Job Success

Scimaxconsulting interview tips for GCP Senior Auditor

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

Before the Interview:

Research: Learn about the Scimaxconsulting'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.

Additional Tips:

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

Be Honest: Don't exaggerate your skills or experience.

Be Positive: Focus on your strengths and accomplishments.

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 Senior Auditor interview at Scimaxconsulting, 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 Scimaxconsulting'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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