Senior Manager QA Auditor GCP Strategy

Regeneron; United Kingdom; Remote; GBP 90,000 - 140,000; Full time

Job summary

Regeneron is seeking a Senior Manager, GCP Audit Strategy in Global Development Quality Assurance to lead risk-based audit planning across therapeutic areas and studies. This remote-friendly role collaborates with cross-functional teams and external auditors while ensuring audits align with approved programs and timelines.

You will drive strategic programs, identify trends from audit outcomes, and present findings to Global Development leadership.

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.

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

Skills

GCP audit strategy

Stakeholder management

Project management

Regulatory inspections

Communication skills

Education

Bachelor’s degree

Job description

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

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 centres, 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.

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.

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.