Manager, Quality Assurance – Good Clinical Practice, Auditor Strategy

Regeneron

Manager, Good Clinical Practices Audit Strategy guiding and leading management of audit strategy programs. Creating risk-based audit plans and ensuring audits meet quality standards and compliance requirements.

Posted 5/27/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $114,800 - $187,400 per yearWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Good Clinical Practice (GCP)audit strategyaudit risk assessmentscompliance projectsregulatory inspectionsFDA regulationsEU regulationsICH guidance documentsproject managementcollaborator management

Soft Skills

leadershipcommunicationnegotiationtrainingstrategic thinkingproblem-solvingrisk managementreportingtrend analysiseducation

Industry Keywords

clinical auditsrisk-based auditcompliance risksinvestigator sitesSponsorsCROsaudit programsquality trendsGlobal Developmentaudit outcomes

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Guide and lead management of Good Clinical Practice Audit Strategy Programs
Create strategic partnerships and direct risk-based audit activities
Develop audit risk assessments and implement audit risk-based strategies
Ensure audits are conducted in accordance with approved audit programs
Maintain core study specific information for auditors
Apply audit outcomes to identify quality trends and communicate compliance risks
Represent on complex compliance projects
Draft and issue periodic reports to management
Provide education and/or training to Global Development departments

Requirements

What you’ll need

Bachelor’s degree with 6+ years of industry experience
4+ years of direct GCP strategy or audit experience
Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs
Knowledge of the FDA and EU regulations and ICH guidance documents
Strong track record of project management, collaborator management and negotiation of complex situations

Benefits

Comp & perks

health and wellness programs (including medical, dental, vision, life, and disability insurance)
fitness centers
401(k) company match
family support benefits
equity awards
annual bonuses
paid time off
paid leaves (e.g., military and parental leave)