Freelance GCP Auditor (multiple openings)

ProPharma; Raleigh (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking freelance GCP Auditors to lead quality assurance projects and conduct GCP audits across various specialized areas. With over 20 years of experience in advancing scientific breakthroughs, this role offers the opportunity to work with a dynamic team dedicated to quality and compliance in the biotech and pharmaceutical sectors. Candidates should possess deep expertise in GCP compliance and a strong background in clinical auditing, along with exceptional leadership and communication skills. This is a chance to contribute to impactful projects while fostering a diverse and inclusive workplace culture.

Qualifications

• 10+ years of clinical compliance and GCP auditing experience.
• Proven track record of managing high-performance teams.

Responsibilities

• Conduct GCP audits including biologics and vaccines.
• Draft and refine Standard Operating Procedures (SOPs).

Skills

GCP compliance knowledge

Audit experience

SOP writing

Regulatory response development

Leadership skills

Analytical skills

Communication skills

Education

Bachelor’s degree in a scientific discipline

Graduate degree

Job description

Freelance GCP Auditor (multiple openings)

Apply locations United States time type Full time posted on Posted 4 Days Ago job requisition id JR 6429

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. As the world’s largest RCO (Research Consulting Organization), 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.

What You’ll Do:

Lead Quality Assurance Projects

1. Conduct GCP audits, including specialized areas such as biologics, vaccines, Cell/Gene therapies.
2. Develop and oversee Quality Management Systems (QMS).

Drive Technical Excellence

1. Draft and refine Standard Operating Procedures (SOPs).
2. Offer tailored GxP compliance consulting based on client needs.
3. Stay at the forefront of regulatory and technological changes to deliver cutting-edge solutions.

What We’re Looking For:

Experience & Expertise

1. Bachelor’s degree in a scientific discipline (graduate degree preferred).
2. 10+ years of clinical compliance and GCP auditing experience, with at least 5 years in a leadership or management role.
3. Proven track record of managing high-performance teams and complex projects.

Technical Skills

1. Deep understanding of GCP compliance requirements.
2. Experience performing audits.
3. Proficiency in SOP writing and regulatory response development.

Desired Qualities

1. Exceptional communication and persuasion skills.
2. Strong analytical abilities and attention to detail.
3. 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.