Job Title: Contract Quality Compliance Consultant

Company: Global CRO

Location: Remote – US-Based Candidates Only

Employment Type: Contract (Freelance / Part-Time or Full-Time)

About the Role:

BioTalent is partnering with a leading Contract Research Organization (CRO) that is seeking an experienced Quality Compliance Consultant to provide strategic guidance on regulatory compliance, quality management, and GxP auditing. This contract position offers an excellent opportunity to work with a top-tier CRO, ensuring that quality and compliance standards align with FDA, ICH, and global regulatory requirements.

This is a fully remote position open to experienced consultants based in the United States.

Key Responsibilities:

• Provide expert guidance on quality compliance for clinical trials, regulatory submissions, and GxP operations.
• Conduct audits (GCP, GLP, GMP, and/or GVP) to ensure compliance with regulatory standards and industry best practices.
• Support the development and maintenance of Quality Management Systems (QMS), SOPs, and internal compliance frameworks.
• Assist with inspection readiness and act as an advisor for FDA, EMA, and other regulatory agency inspections.
• Review and assess compliance risks, CAPA (Corrective and Preventive Action) plans, and deviations.
• Collaborate with internal teams and external stakeholders to align quality initiatives with business and regulatory requirements.
• Provide training and mentorship on compliance policies and industry best practices.
• Stay up to date with evolving regulatory changes and advise on their impact on clinical operations.

Candidate Profile:

Qualifications & Experience:

• Education: Bachelor’s or advanced degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
• Experience:
  • Minimum 8+ years of experience in quality compliance, GxP auditing, or regulatory compliance within a CRO, biotech, pharmaceutical, or medical device company.
  • Proven experience with GCP, GLP, GMP, or GVP compliance and quality assurance.
  • Strong knowledge of FDA, ICH, EMA, and other global regulatory requirements for clinical trials and drug development.
  • Experience with CAPA management, regulatory inspections, and internal/external audits.
  • Previous consulting experience or a track record of working on contract-based compliance projects is highly desirable.

Skills & Attributes:

• Strong analytical and problem-solving skills to assess compliance risks and implement solutions.
• Excellent communication and interpersonal skills for stakeholder engagement.
• Ability to work independently in a remote setting, managing multiple projects efficiently.
• Detail-oriented with a proactive approach to regulatory and quality challenges.
• Proficiency in electronic quality systems (eQMS) and compliance tracking tools is a plus.

What’s on Offer:

• Flexible contract arrangement (part-time or full-time) with competitive hourly/daily rates.
• Fully remote role with the opportunity to collaborate with a leading CRO.
• Exposure to high-impact projects in clinical trials, regulatory compliance, and quality assurance.
• The opportunity to work with top-tier clients and play a key role in ensuring regulatory excellence.