Senior Manager GCP Quality

Senior Manager GCP Quality

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 Quality Management - Global Development to join our Global Development Quality team, supporting our global clinical development organisation in a hybrid work model. In this role, you will lead risk-based quality management across clinical trials while collaborating with study teams, clinical functions, contract research organisations, and quality colleagues. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Multiple locations are being considered for this role (Hybrid)

Discover your role:

• Lead risk-based quality management across assigned clinical trials

• Drive protocol-stage Quality Risk Assessment and Control Tracker activities under ICH E6 R3

• Manage quality issues, audit responses, corrective actions, preventive actions, and trend analysis

• Partner with study leads, monitoring teams, and contract research organisations on site risks

• Escalate significant quality events and trends to Executive Quality Leadership

• Support inspection readiness, responses, and follow-up actions across relevant functions

• Manage onboarding, development goals, coaching, performance discussions, and team administration

• You champion quality, integrity, continuous learning, and trusted partnerships

This role requires:

• Bachelor’s degree and eight years’ relevant healthcare or pharmaceutical industry experience

• Quality, compliance, clinical development, Good Clinical Practice, or Good Pharmacovigilance Practice experience

• Advanced risk-based quality management, risk assessment, and compliance knowledge

• Experience managing complex issues, regulatory inspections, and inspection readiness

• Subject matter expert, process owner, training, presentation, and staff management experience

• Process improvement, project management, prioritisation, and time management skills

• Advanced Microsoft Outlook, Word, Excel, and PowerPoint skills

• Strong communication, collaboration

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 during the recruitment process.

This is the posting for jobs in Canada? Actually the line reads: For jobs in Canada: this posting is for an existing position.

Salary Range (annually) €86,800.00 - €141,200.00

About Us

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

About Regeneron