Senior Manager GD GCP Auditing (Ireland)

BioSpace; Ireland (WV); Remote; USD 98,000 - 159,000; Full time

Job summary

Regeneron is seeking a Senior Manager GD GCP Auditing to lead risk-based quality auditing and strengthen GCP compliance within the Global Development Quality Assurance team. The role supports a global development organization in a remote work model and involves travel 30-40% domestically and internationally.

The ideal candidate has a Bachelor’s degree with 8+ years in industry, 5+ years GCP auditing, and deep knowledge of FDA/EU regulations, ICH guidance, and GCP requirements.

Qualifications

• 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 and EU regulations, ICH guidance, and GCP requirements.
• Experience with process, site, vendor, and partner audits.
• Experience with regulatory inspections involving investigator sites, sponsors, or CROs.
• Ability to independently manage complex GxP issues and high-priority audits.
• Strong leadership, stakeholder management, collaboration, and negotiation skills.
• Excellent written and verbal communication and attention to detail.

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.
• Build trusted stakeholder partnerships.

Skills

Leadership

Project management

Stakeholder management

Communication skills

Problem solving

Negotiation

Travel readiness

Education

Bachelor's degree

Master's degree preferred

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 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

Work model: Remote

Discover Your Role

• 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.
• Representing Quality Assurance on complex compliance projects and initiatives.
• Interpret policies, standards, and regulations to address critical issues.
• Support regulatory inspections and inspection room activities.
• You thrive in a dynamic environment and build trusted stakeholder partnerships.

This Role Requires

• Bachelors degree with 8+ years of relevant industry experience; Masters 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.
• 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.
• Willingness to travel 30-40% domestically and internationally.

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.

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 onsite.

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.

Salary Range (annually)

86,800.00 - 141,200.00