GCP / GMP Auditor (Clinical Research & Quality Assurance)
📍 Location: Canada (Remote / Hybrid)
🕒 Type: Full-Time / Contract
Quick Overview (Featured Snippet Ready)
The GCP/GMP Auditor ensures compliance with ICH-GCP and GMP standards by conducting audits, identifying risks, implementing CAPA, and supporting regulatory inspection readiness across clinical trials and manufacturing systems.
About Conduct Research
Conduct Research / MD Trials is a Canada-based CRO & SMO focused on:
- Clinical trial execution
- GCP compliance & auditing
- Patient recruitment & retention
- Regulatory and quality systems
We help sponsors and sites achieve high-quality, compliant, and successful clinical trials.
Your Role in Our Team
As a GCP / GMP Auditor, you will be responsible for building and maintaining a strong compliance framework across clinical and manufacturing operations.
You will work closely with:
- Clinical trial sites
- Sponsors and CRO partners
- Internal QA and regulatory teams
Your work will directly impact data integrity, patient safety, and regulatory approvals.
Key Responsibilities
- Conduct GCP and GMP audits (site, vendor, internal, and system audits)
- Evaluate compliance with ICH-GCP, GMP, FDA, and Health Canada guidelines
- Review Trial Master Files (TMF), SOPs, validation reports, and batch records
- Identify risks and implement CAPA (Corrective & Preventive Actions)
- Support inspection readiness and regulatory audits
- Develop and improve Quality Management Systems (QMS)
- Prepare detailed audit reports and compliance documentation
- Train teams on GCP/GMP best practices and regulatory expectations
What You Bring
- Degree in Life Sciences, Pharmacy, Biotechnology, or related field
- 3–7+ years of experience in QA, auditing, or clinical research
- Strong understanding of ICH-GCP, GMP, and regulatory frameworks
- Hands-on experience with GCP/GMP audits and inspections
- Excellent documentation and analytical skills
Preferred Experience
- Certification in GCP / QA / Clinical Research
- Experience with CROs, SMOs, or sponsor-side auditing
- Exposure to oncology, infectious diseases, or medical device trials
- Experience in risk-based auditing and remote inspections
How You Will Succeed
- Strong attention to detail and compliance mindset
- Ability to manage multiple audits and deadlines
- Clear and professional reporting and communication
- Proactive approach to risk identification and resolution
Why Join Conduct Research
- Work on real clinical trials with measurable impact
- Gain exposure to global regulatory environments
- Be part of a quality-first CRO
- Grow into leadership roles in QA and regulatory affairs
Application Process
- Submit your application
- Initial screening
- Technical evaluation
- Final interview
- Offer
How to Apply
📧 Email your CV to: clinicaltrials@conductresearch.ca