Senior Manager GCP Quality

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

Benefits offered by this job

Annual bonuses

Equity awards

401(k) company match

Health and wellness programs

Paid time off

Job summary

Regeneron seeks a Senior Manager, GCP Quality Management - Global Development to lead risk-based quality across clinical trials in a globally integrated, hybrid work model.

You will collaborate with study teams, CROs, and quality colleagues to ensure inspection readiness and audit responses while mentoring a high-performing team; drive continuous improvement across programs.

Qualifications

• Bachelor's degree in healthcare, pharmaceuticals, or related field and eight years of relevant experience.
• Experience in Good Clinical Practice, Good Pharmacovigilance Practice, or regulatory quality systems.
• Advanced risk-based quality management, risk assessment, and compliance knowledge.
• Experience leading complex issues, regulatory inspections, and inspection readiness.
• Subject matter expert, process owner, training, and staff management 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 CROs 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.

Skills

Quality management

Risk assessment

Regulatory inspections

Staff management

Project management

Communication

Education

Bachelor's degree

Tools

Microsoft Outlook

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

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

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. If you have any questions, please speak with your recruiter.

Salary Range (annually) $134,400.00 - $219,200.00

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.

For jobs in Canada: this posting is for an existing position.

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.