Senior Manager GD GCP Auditing (Ireland)

BioSpace; Ireland (WV); Remote; USD 97,000 - 158,000; Full time

Job summary

Regeneron is seeking a Senior Manager GD GCP Auditing to lead risk-based quality auditing activities within the Global Development Quality Assurance team, supporting the global development organization in a remote work model.

You will oversee end-to-end GCP audits, develop audit programs for clinical studies, and drive issue resolution while collaborating with external partners and quality stakeholders worldwide.

Qualifications

• Bachelor's 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.

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.
• 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.

Skills

Project management

Stakeholder management

Negotiation

Communication skills

Attention to detail

Independent work

Education

Bachelor's degree

Master'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 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.

When & Where

• 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.

Does this sound like you?

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.

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. Please speak with your recruiter and hiring manager for more information about onsite 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.

Salary Range (annually)

86,800.00 - 141,200.00