GCP/GLP/GCLP Auditor and SOP Technical Writer, QA Compliance Consultant. US based.
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. Join Our Team: GCP/GLP/GCLP Auditor & SOP Technical Writer, QA Compliance Consultant 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.* Apply Job!
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