What are the responsibilities and job description for the Freelance GCP Auditor (multiple openings) position at ProPharma?
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
We are in need of freelance GCP Auditors to perform multiple US-based audits throughout 2025.
** Not open to 3rd party agencies. **
What You’ll Do
As a Freelance GCP Auditor, you will:
Lead Quality Assurance Projects
Experience & Expertise
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
We are in need of freelance GCP Auditors to perform multiple US-based audits throughout 2025.
** Not open to 3rd party agencies. **
What You’ll Do
As a Freelance GCP Auditor, you will:
Lead Quality Assurance Projects
- Conduct GCP audits, including specialized areas such as biologics, vaccines, Cell/Gene therapies.
- Develop and oversee Quality Management Systems (QMS).
- Draft and refine Standard Operating Procedures (SOPs).
- Offer tailored GxP compliance consulting based on client needs.
- Stay at the forefront of regulatory and technological changes to deliver cutting-edge solutions.
Experience & Expertise
- Bachelor’s degree in a scientific discipline (graduate degree preferred).
- 10 years of clinical compliance and GCP auditing experience, with at least 5 years in a leadership or management role.
- Proven track record of managing high-performance teams and complex projects.
- Deep understanding of GCP compliance requirements.
- Experience performing audits
- Proficiency in SOP writing and regulatory response development.
- Exceptional communication and persuasion skills.
- Strong analytical abilities and attention to detail.
- Commitment to fostering diversity, equity, and inclusion in the workplace.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***