GCP Auditor - Biophase : Job Details

This range is provided by BioPhase. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$130,000.00/yr - $145,000.00/yr

Direct message the job poster from BioPhase

Senior Clinical Recruiter at BioPhase Solutions | Life Sciences

Senior GCP Auditor – Remote

Summary:

The Senior GCP Auditor ensures compliance SOPs, ICH GCP E6 (R2), FDA regulations, and study protocols. This role supports inspection readiness and collaborates cross-functionally with Clinical Operations, Regulatory, PV, Medical Writing, and Data Management.

Key Responsibilities:

• Maintain and update the Clinical Trial Quality Management System.
• Plan and conduct internal, vendor, and clinical site audits.
• Prepare audit documentation and follow up on findings and CAPAs.
• Review protocols, ICFs, and study-related documents for compliance.
• Support GCP training and quality issue resolution across departments.
• Track deviations, CAPAs, and complaints.
• Lead inspection readiness initiatives and assist during regulatory inspections.
• Represent QA in cross-functional meetings.

Qualifications:

• Bachelor's in life sciences or engineering with 7+ years of GCP experience, or Master's with 4+ years.
• CQA or audit certifications a plus.
• Experience with TMF or electronic document systems preferred.

Skills:

• In-depth knowledge of ICH GCP E6 (R2).
• Strong auditing, organizational, and communication skills.
• Ability to manage multiple priorities in a dynamic environment.

Additional Info:

• Remote role with flexible hours.
• Travel up to 30% may be required.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionOther
• IndustriesBiotechnology Research and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at BioPhase by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Get notified about new Auditor jobs in San Francisco Bay Area.

San Francisco Bay Area $155,000 - $195,000 1 month ago

Accountant – Financial Reporting & Compliance

Walnut Creek, CA $90,000 - $110,000 4 days ago

San Francisco, CA$145,000.00-$170,000.007 months ago

San Francisco, CA$85,000.00-$100,000.007 months ago

San Francisco Bay Area$75.00-$90.002 weeks ago

San Francisco Bay Area$70.00-$120.003 weeks ago

San Francisco, CA$85,000.00-$115,000.0019 hours ago

San Jose, CA$70,000.00-$95,000.004 days ago

San Francisco, CA$100,000.00-$115,000.007 months ago

San Francisco, CA$160,000.00-$200,000.007 months ago

Audit Senior (Government) - FULLY REMOTE

San Jose, CA$75,000.00-$90,000.002 weeks ago

San Francisco Bay Area$60.00-$70.002 weeks ago

Assistant Controller - Growing Manufacturing Company - 100% Remote

San Jose, CA$76,900.00-$108,200.0021 hours ago

San Francisco, CA$80,000.00-$100,000.001 day ago

San Jose, CA $140,000 - $170,000 16 hours ago

San Francisco, CA $65,000 - $80,000 4 days ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr