Senior Manager QA Auditor GCP Strategy

Overview

At Regeneron, we use science and innovation to develop life changing medicines for people with serious diseases. We are seeking a Senior Manager, GCP Audit Strategy, Global Development to join our Global Development Quality Assurance (GDQA) and support the Global Development organization in a remote work mode. In this role, you will lead risk based audit strategy programs and oversee compliance across therapeutic areas, studies, and audit activities while collaborating with Global Development teams, auditors, and cross functional stakeholders.

Location

UK Remote - Ireland Remote

Responsibilities

• 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

Qualifications

• 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

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits.

EEO Statement

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.