Freelance GMP Auditor (Canada-based)
Location: Canada
Job Category: Quality & Compliance
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About ProPharma:
For the past 20 years, ProPharma has been a trusted partner for biotech, medical device, and pharmaceutical companies, delivering advice and expertise that advances scientific breakthroughs. Through an advise-build-operate model, ProPharma supports the entire product lifecycle with services in regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology.
The Position:
As a Freelance GMP Auditor, you will lead Quality Assurance projects, conduct GMP audits across specialized areas such as biologics, vaccines, and cell/gene therapies, and develop and oversee Quality Management Systems (QMS). This role is a freelance, Canada-based position and is not open to third-party agencies.
Responsibilities:
Lead Quality Assurance projects and drive the successful delivery of client objectives.
Conduct comprehensive GMP audits, including specialized audits in biologics, vaccines, and cell/gene therapies.
Develop and manage Quality Management Systems (QMS) tailored to client needs.
Draft and refine Standard Operating Procedures (SOPs) for regulatory and operational excellence.
Provide GxP compliance consulting customized to specific client requirements.
Stay current with regulatory and technological changes to ensure cutting-edge solutions.
Qualifications:
Bachelor's degree in a scientific discipline (graduate degree preferred).
Minimum 10 years of experience in clinical compliance and GMP auditing, with at least 5 years in a leadership or management role.
Demonstrated success in managing high-performance teams and complex projects.
Deep understanding of GMP compliance requirements and audit processes.
Proficiency in SOP writing and regulatory response development.
Strong communication, persuasion, and analytical skills.
Exceptional attention to detail.
Commitment to fostering diversity, equity, and inclusion in the workplace.
Workplace Commitment:
ProPharma celebrates diversity and strives to create a workplace where each person can be their authentic self. The company is committed to diversity, equity, and inclusion, fostering an environment where innovation, collaboration, and entrepreneurial spirit are encouraged.
Additional Information:
ProPharma Group does not accept unsolicited resumes from recruiters or third parties.
Please refrain from making phone calls or sending emails regarding this posting.
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