Build our future together
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Associate Director, Quality Standards and Continuous Improvement to join our Global Development Quality team, supporting quality management system oversight, governance, quality events and continuous improvement across Global Development. In this role, you will help maintain effective quality standards and processes while collaborating with internal leaders, functional stakeholders and cross-functional teams. This position offers the opportunity to contribute to a fast-growing, science-driven organisation making a meaningful difference to patients worldwide.
Oversee the end-to-end Issue Management framework, ensuring standardized, compliant, and inspection-ready practices.
Define and evolve Issue Management and Quality Event strategies to support scalability, efficiency, and consistency.
Drive cross-functional alignment across Quality Event Leads (QEL) and functional teams to ensure consistent and right sized approach to issue management and quality decision-making.
Lead QEL forums and provide SME guidance on QMS governance, continuous improvement, and inspection readiness.
Ensure consistency in investigations, root cause analysis, CAPAs and documentation standards.
Lead and Develop line reports whilst also supporting the broader QEL community through coaching, standard setting, and knowledge sharing
Monitor Issue Management performance through metrics and trend analysis.
Bachelor’s degree with at least 10 years of relevant healthcare or pharmaceutical industry experience.
Experience in quality, compliance, quality management, quality assurance or clinical development.
Expertise or transferable skills related to Good Clinical Practice or Good Pharmacovigilance Practice.
Experience training, supervising, mentoring, developing staff and leading a small team.
Advanced knowledge of quality management system oversight, quality governance and continuous improvement.
Experience participating in, managing and leading regulatory agency inspections.
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 to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
