Senior Manager, GCP Auditing

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $134.4k - $219.2k / year

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Regeneron

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1988

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 Post-IPO Equity on 2023-10

Healthcare • Manufacturing • Biotechnology

Regeneron is a biotechnology company dedicated to turning scientific discoveries into life-changing medicines. The company focuses on a range of serious diseases including allergic, cardiovascular, and metabolic diseases, neuroscience, oncology, hematology, ophthalmology, and rare diseases. It achieves this by integrating biology and technology to develop cutting-edge biologics and genetic medicines. Regeneron is committed to health equity, environmental sustainability, and supporting future STEM talent through initiatives like the Regeneron Science Talent Search. By maintaining high ethical standards and corporate responsibility, Regeneron aims to push the boundaries of science for better healthcare solutions.

📋 Description

• Lead end-to-end GCP audits across internal and external global activities • Schedule, conduct, report, and follow up on routine and directed audits • Develop and execute risk-based audit programs for assigned clinical studies • Identify compliance issues and drive process improvements and standardization • Represent Quality Assurance on complex compliance projects and initiatives • Interpret policies, standards, and regulations to address critical issues • Support regulatory inspections and inspection room activities • Collaborate with Global Development teams, external partners, and quality stakeholders • Build trusted stakeholder partnerships

🎯 Requirements

• Bachelor’s degree with 8+ years of relevant industry experience; Master’s degree preferred • At least 5 years of direct Good Clinical Practice audit experience • Expert knowledge of FDA regulations, European Union regulations, ICH guidance, and GCP requirements • Experience conducting process, site, vendor, and partner audits • Experience with regulatory inspections involving investigator sites, sponsors, or Contract Research Organizations • Ability to independently manage complex GxP compliance issues and high-value priorities • Strong leadership skills with experience interfacing with senior leaders • Excellent project management, stakeholder management, collaboration, and negotiation skills • Strong problem-solving, written, and verbal communication skills • Ability to work independently, take initiative, and perform effectively in ambiguous environments • High attention to detail, accuracy, and organizational awareness • Willingness to travel 30-40% domestically and internationally

🏖️ Benefits

• Annual bonuses or other incentive plans • Equity awards • Pension or retirement benefits • 401(k) company match • Health and wellness programs • Fitness centers • Medical, dental, vision, life, and disability insurance benefits • Paid time off • Family support benefits • Reasonable accommodation during the recruitment process for applicants with known disabilities or chronic illnesses