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
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Conduct GCP audits, including specialized areas such as biologics, vaccines, Cell/Gene therapies.
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Develop and oversee Quality Management Systems (QMS).
Drive Technical Excellence
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Draft and refine Standard Operating Procedures (SOPs).
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Offer tailored GxP compliance consulting based on client needs.
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Stay at the forefront of regulatory and technological changes to deliver cutting-edge solutions.
What We’re Looking For:
Experience & Expertise
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Bachelor’s degree in a scientific discipline (graduate degree preferred).
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10+ years of clinical compliance and GCP auditing experience, with at least 5 years in a leadership or management role.
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Proven track record of managing high-performance teams and complex projects.
Technical Skills
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Deep understanding of GCP compliance requirements.
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Experience performing audits
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Proficiency in SOP writing and regulatory response development.
Desired Qualities
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Exceptional communication and persuasion skills.
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Strong analytical abilities and attention to detail.
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Commitment to fostering diversity, equity, and inclusion in the workplace.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
Top Skills
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