OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team as a remote Contract, Auditor. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

POSITION SUMMARY & RESPONSIBILITIES

This position will require up to 25% travel, domestic and international. The contractor will provide GxP support for the vendor management and audit program. This role ensures compliance with FDA, ICH, and global requirements while supporting integration of acquired programs and driving continuous quality system improvements.

Responsibilities:

• Execute the annual GCP/GVP audit plan by leading vendor audits and reviewing questionnaires. 
• Manage audit issue resolution and maintain the audit observation database, delivering metrics and trend analyses to leadership. 
• Oversee GxP vendor lifecycle management, including risk assessments, initial qualification, requalification, and maintenance of the Approved Vendor List. 
• Serve as a key QA point of contact for vendor-related audits, performance oversight, and compliance decision-making. 
• Provide support during GxP health authority inspections. 
• Support development and maintenance of GxP quality documentation, including SOPs, policies, templates, and work instructions. 
• Oversee maintenance of clinical site and vendor quality documentation archives. 

EXPERIENCE

• Minimum five years of experience in GCP/GVP, including both external and internal auditing. GLP/GCLP vendor management experience is a plus. 
• Extensive experience with global clinical trial conduct; knowledge and understanding of ICH E6 GCP Guideline, FDA regulations, and EU requirements. 
• Previous experience facilitating and/or supporting Regulatory Authority inspections. 
• Previous experience in development and oversight of Quality Management Systems. 
• Excellent interpersonal skills, personal integrity, professional manner, and the ability to gain respect and develop strong working relationships with cross-functional personnel at all levels. 

EDUCATION 

• Bachelor’s degree in Life Sciences with 10 years in pharmaceutical or biotech drug development. (Advanced degree preferred)

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Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].