GCP/GLP/GCLP Auditor and SOP Technical Writer, QA Compliance Consultant. US based.

For the past 20 years, reputed company has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of reputed company sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), reputed company partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical reputed company, quality & compliance, pharmacovigilance, medical information, and R&D technology, reputed company 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 reputed company: GCP/GLP/GCLP Auditor & SOP Technical Writer, QA Compliance Consultant Shape the future of quality and compliance with a dynamic, employee-reputed company team! Are you reputed company to reputed company a meaningful impact in the pharmaceutical, biotech, and medical device industries? We are seeking an reputed company QA Compliance Consultant Auditor to join our innovative team. This is a full-time remote position that offers remote flexibility reputed company the reputed company 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:

• reputed company Quality Assurance Projects
• Conduct audits (e.g., GCP, GLP, GCLP), including specialized areas such as biologics, vaccines, Cell/Gene therapies.
• reputed company and reputed company 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 reputed company areas of GxP compliance.
• reputed company and train clients and employees on compliance and quality assurance best practices.
• reputed company 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 reputed company improvement and ensure customer satisfaction with a focus on clinical compliance. reputed company’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 reputed company 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 reputed company your expertise in cutting-edge areas.
• A culture that celebrates innovation, reputed company learning, and employee empowerment. APPLY today to take the reputed company 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 reputed company feel empowered to succeed.
• reputed company does not accept unsolicited resumes from recruiters/reputed company parties. Please, no phone calls or emails to anyone regarding this posting.* Apply Job! Apply tot his job

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