Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Target Resume Now
About the Role
Join Regeneron's Global Development Quality team as a Senior Manager, GCP Quality Management. You will lead risk-based quality management across clinical trials, collaborating with study teams, clinical functions, contract research organisations, and quality colleagues. This role supports our global clinical development organisation and offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
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
- Champion quality, integrity, continuous learning, and trusted partnerships
Requirements
- 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 and collaboration skills
Skills
- Risk-based quality management
- Risk assessment
- Compliance
- Process improvement
- Project management
- Prioritisation
- Time management
- Microsoft Outlook
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Communication
- Collaboration
Location
- Multiple locations considered (Hybrid)
Work Type
- Hybrid
Experience Level
- Senior Manager
Education Level
- Bachelor's degree
Salary/Compensations
- $134,400.00 - $219,200.00
Benefits
- 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
- Family support benefits
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- We are committed to building a workplace with an inclusive culture.
- We believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.
Equal Opportunity
- 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.