Senior Manager GCP Quality

Regeneron Pharmaceuticals, Inc; Armonk (NY); Hybrid; USD 134,000 - 219,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Manager, GCP Quality Management - Global Development to lead risk-based quality management across clinical trials in a hybrid work model.

You will partner with study teams, CROs, and quality colleagues to drive risk assessment, control tracking, and issue resolution while supporting inspection readiness. The role emphasizes leadership, process improvement, and collaboration across global development quality functions to ensure patient safety

Qualifications

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

Responsibilities

• 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

Skills

Quality management

Risk assessment

Compliance

Inspection readiness

Staff management

Project management

Time management

Communication

Collaboration

Process improvement

Education

Bachelor's degree

Tools

Microsoft Office

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 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? 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.

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

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. Please speak with your recruiter and hiring manager for more information about on‑site 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)

$134,400.00 - $219,200.00