Senior Manager GD GCP Auditing (Ireland)

About the role

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager GD GCP Auditing to join our Global Development Quality Assurance team, supporting our global development organization in a remote work model. In this role, you will lead risk-based quality auditing activities and strengthen GCP compliance while collaborating with Global Development teams, external partners, and quality stakeholders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Location

Ireland; remote work model.

Responsibilities

• Lead end-to-end GCP audits across internal and external global activities.
• Schedule, conduct, report, and follow up on routine and directed audits.
• Develop and execute risk-based audit programs for assigned clinical studies.
• Identify compliance issues and drive process improvements and standardization.
• Represent Quality Assurance on complex compliance projects and initiatives.
• Interpret policies, standards, and regulations to address critical issues.
• Support regulatory inspections and inspection room activities.

Requirements

• Bachelor's degree with 8+ years of relevant industry experience; Master's degree preferred.
• At least 5 years of direct Good Clinical Practice audit experience.
• Expert knowledge of FDA regulations, European Union regulations, ICH guidance, and GCP requirements.
• Experience conducting audit types including process, site, vendor, and partner audits.
• Experience with regulatory inspections involving investigator sites, sponsors, or Contract Research Organizations.
• Ability to independently manage complex GxP compliance issues and high-value priorities.
• Willingness to travel 30–40% domestically and internationally.

Skills

• Strong leadership skills with experience interfacing with senior leaders.
• Excellent project management, stakeholder management, collaboration, and negotiation skills.
• Strong problem-solving, written, and verbal communication skills.
• Ability to work independently, take initiative, and perform effectively in ambiguous environments.
• High attention to detail, accuracy, and organizational awareness.

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., visit careers.regeneron.com/en/working-at-regeneron/total-rewards/; for other locations, details will be provided during the recruitment process.

Pay

For jobs in Canada: salary range (annually) 86,800.00 – 141,200.00. 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 may apply and influence certain elements of pay or benefits.