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Freelance Gcp Auditor (Canada-Based)

10+ years
Not Disclosed
10 April 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Freelance GCP Auditor – Canada-Based

Location: Canada
Job Category: Quality Assurance / Clinical Research

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About ProPharma:

For over 20 years, ProPharma has been a trusted partner to biotech, medical device, and pharmaceutical companies, advancing scientific innovations and introducing breakthrough therapies. Through an advise-build-operate model across the full product lifecycle, ProPharma delivers customized consulting services in regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology.

The Position:

ProPharma is seeking a Freelance GCP Auditor based in Canada. This role requires a seasoned professional to conduct GCP audits, oversee Quality Management Systems (QMS), and provide expert GxP compliance consulting.

Responsibilities:

  • Lead quality assurance projects with a focus on clinical research.

  • Conduct GCP audits, including specialized sectors like biologics, vaccines, and cell/gene therapies.

  • Develop, implement, and manage Quality Management Systems (QMS).

  • Draft, refine, and maintain Standard Operating Procedures (SOPs).

  • Provide customized GxP compliance consulting aligned to client needs.

  • Stay updated on regulatory changes and new technologies to deliver cutting-edge solutions.

Qualifications:

  • Bachelor’s degree in a scientific discipline (graduate degree preferred).

  • Minimum of 10 years in clinical compliance and GCP auditing.

  • At least 5 years of experience in a leadership or management role.

  • Proven track record in leading high-performance teams and managing complex projects.

Technical Skills:

  • Comprehensive understanding of GCP compliance standards and requirements.

  • Hands-on experience conducting audits.

  • Expertise in writing SOPs and developing regulatory responses.

Desired Qualities:

  • Outstanding communication and persuasion skills.

  • Strong analytical thinking and meticulous attention to detail.

  • Dedication to promoting diversity, equity, and inclusion in the workplace.

Workplace Commitment:

ProPharma is committed to building an inclusive environment where employees can be their authentic selves. They celebrate diversity and encourage innovation, collaboration, and entrepreneurial spirit across all teams.

Additional Information:

  • This position is not open to third-party agencies.

  • Please do not contact ProPharma by phone or email regarding this job posting.