[Hiring] Senior Manager QA Auditor GCP Strategy @Regeneron Pharmaceuticals

Role Description

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), supporting our 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.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Discover your role:

• 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

• 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

Company Description

Regeneron is committed to building a workplace with an inclusive culture. We are 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 necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually): €86,800.00 - €141,200.00