Senior Manager GCP Quality

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

Job summary

Regeneron is seeking a Senior Manager, GCP Quality Management – Global Development to lead risk-based quality oversight across clinical trials in a hybrid work model. You will partner with study teams, CROs, and quality colleagues to drive ICH-compliant QA activities and readiness for inspections.

You will manage quality issues, CAPAs, and trend analyses, champion a culture of integrity, and coach a diverse team while ensuring timely, compliant findings and continuous improvement across global

Qualifications

• Bachelor's degree required with 8+ years in healthcare or pharmaceutical industry.
• Experience with Quality, compliance, clinical development, GCP or GVP.
• Advanced risk-based quality management, risk assessment and compliance knowledge.

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 functions.
• Manage onboarding, development goals, coaching, performance discussions, and team administration.
• Champion quality, integrity, continuous learning, and trusted partnerships.

Skills

Quality management

GCP knowledge

Risk assessment

Regulatory inspections

Leadership

Education

Bachelor'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, GCP Quality Management – Global Development to join our Global Development Quality team, supporting our global clinical development organization 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 organizations, 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 organizations 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

• Bachelors 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

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.

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.

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.

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

Salary Range (annually)

$134,400.00 - $219,200.00

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.