Senior Manager QA Auditor GCP Strategy

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, 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.   When & where:   UK Remote - Ireland Remote   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   You collaborate effectively with stakeholders across global functions   You navigate ambiguity while prioritizing multiple complex activities   10-20% travel might be required This role requires:   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       Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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.   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. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or 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. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter.  Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required