Senior Manager, QA Auditor, GCP Strategy

Regeneron

Senior Manager, GCP Audit Strategy leading risk-based audit programs and compliance in a remote role at Regeneron. Collaborating with Global Development teams to ensure quality assurance standards.

Posted 6/23/2026full-timeRemote • 🇮🇪 IrelandSenior💰 €86,800 - €141,200 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead risk-based audit planning across therapeutic areas and studies
Drive strategic audit programs using risk indicators from study teams
Ensure audits align with approved programs and scheduled timelines
Manage audit outcomes to identify trends and communicate risks
Represent quality assurance on complex cross-functional initiatives
Deliver reports and metrics to Global Development leadership
Collaborate effectively with stakeholders across global functions
Navigate ambiguity while prioritizing multiple complex activities
10-20% travel might be required

Requirements

What you’ll need

Bachelor’s degree with 8+ years of relevant industry experience
5+ years of GCP audit strategy or audit experience
Knowledge of FDA, EU, and ICH GCP regulations and guidance
Experience supporting or participating in regulatory inspections
Strong project management and stakeholder management capabilities
Excellent written and verbal communication skills with senior audiences.

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GCP audit strategyregulatory inspectionsaudit planningrisk indicatorsaudit outcomesreportingmetrics deliveryproject managementstakeholder management

Soft Skills

communication skillscollaborationnavigating ambiguityprioritization