Senior Manager GD GCP Auditing
About The Position
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager GD GCP Auditing to join our Global Development Quality Assurance team, supporting our global development organization in a remote work model. In this role, you will lead risk-based quality auditing activities and strengthen GCP compliance while collaborating with Global Development teams, external partners, and quality stakeholders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
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 audit types including 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.
Nice To Haves
- Willingness to travel 30-40% domestically and internationally.
Responsibilities
- 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.
- Representing Quality Assurance on complex compliance projects and initiatives.
- Interpret policies, standards, and regulations to address critical issues.
- Support regulatory inspections and inspection room activities.
Benefits
- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- fitness centers
- insurance benefits (e.g. medical, dental, vision, life and disability)
- paid time off
- family support benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
