Senior Manager GCP Quality

BioSpace; Uxbridge (MA); Hybrid; USD 150,000 - 210,000; Full time

Job summary

Regeneron is seeking a Senior Manager, GCP Quality Management - Global Development in a hybrid work model. You will lead risk-based quality management across clinical trials and collaborate with study teams, CROs, and quality colleagues to uphold quality across development programs.

You will escalate significant quality events to leadership, support inspection readiness, and contribute to team onboarding, coaching, and performance discussions, fostering a culture of quality and partnership.

Qualifications

• Bachelor's degree or higher in a healthcare, pharmaceutical, or related field.
• 8+ years of healthcare or pharmaceutical experience with quality/compliance
• Experience in Good Clinical Practice or Good Pharmacovigilance Practice

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, CAPA, and trend analysis.
• Partner with study leads, monitoring teams, and CROs on site risks.
• Escalate significant quality events to Executive Quality Leadership.
• Support inspection readiness, responses, and follow-up actions across functions.
• Lead onboarding, development goals, coaching, and performance discussions for the team.
• Champion quality, integrity, continuous learning, and trusted partnerships.

Skills

Quality management

Clinical development

GCP/GVP

Risk management

Regulatory inspections

Staff management

Project management

MS Office

Communication

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 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

• 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

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.

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.

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. Please speak with your recruiter and hiring manager for more information about onsite 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.