GCP / GCLP Clinical Auditor

ProPharma; Raleigh (NC); Remote; USD 90,000 - 130,000; Full time

Job summary

ProPharma is seeking a GCP/GCLP Clinical Auditor to join their team. This full-time remote position involves leading quality assurance projects, conducting audits, and developing quality management systems. Candidates should have extensive experience in clinical compliance and a strong background in regulatory requirements. Join a dynamic team committed to innovation and excellence in the pharmaceutical and biotech industries.

Benefits

Remote flexibility

Opportunities for monthly travel

Collaborative work environment

Qualifications

• 10+ years of clinical compliance and GCP auditing experience.
• At least 5 years in a leadership or management role.
• Proven track record of managing high-performance teams.

Responsibilities

• Conduct audits (e.g., GCP, GLP, GCLP) including specialized areas.
• Develop and oversee Quality Management Systems (QMS).
• Educate and train clients on compliance and quality assurance best practices.

Skills

GCP compliance

GLP compliance

GCLP compliance

SOP writing

Analytical skills

Communication

Education

Bachelor’s degree in a scientific discipline

Graduate degree preferred

Job description

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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.

Join Our Team: GCP/GCLP Clinical Auditor

Shape the future of quality and compliance with a dynamic, employee-centric consulting team!

Are you ready to make a meaningful impact in the pharmaceutical, biotech, and medical device industries? We are seeking an experienced QA Compliance Consultant Auditor to join our innovative team. This is a full-time remote position that offers remote flexibility within the continental United States and the opportunity for exciting monthly travel to support impactful projects.

What You’ll Do

As a QA Compliance Consultant Auditor, you will:

• Lead Quality Assurance Projects
• Conduct audits (e.g., GCP, GLP, GCLP), including specialized areas such as biologics, vaccines, Cell/Gene therapies.
• Develop and oversee Quality Management Systems (QMS).
• Support clients in responding to regulatory agency actions and implementing CAPAs.
• Drive Technical Excellence
• 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.
• Engage with Clients & Teams
• Represent the company as a trusted advisor in all areas of GxP compliance.
• Educate and train clients and employees on compliance and quality assurance best practices.
• Develop engaging content, such as blogs and social media posts, to promote CQA services.
• Contribute to Business Growth
• Participate in project scoping and sales discussions to align solutions with client needs.
• Promote continuous improvement and ensure customer satisfaction with a focus on clinical compliance.
  

What We’re Looking For

• 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.
• Technical Skills
• Deep understanding of GCP, GLP, and/or GCLP compliance requirements.
• Experience performing audits (minimum 5 audits in the past year preferred).
• Proficiency in SOP writing and regulatory response development.
• Desired Qualities
• Exceptional communication and persuasion skills.
• Strong analytical abilities and attention to detail.
• Commitment to fostering diversity, equity, and inclusion in the workplace.
  

Why Join Us?

• A collaborative and supportive work environment that values your individuality.
• Opportunities to engage in impactful projects and develop your expertise in cutting-edge areas.
• A culture that celebrates innovation, continuous learning, and employee empowerment.
  
  

APPLY today to take the next step in your career with us!

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.***

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Accounting/Auditing and Finance

• Industries

  Business Consulting and Services

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