Senior Manager GCP Quality

BioSpace; Kuah; On-site; MYR 351,000 - 571,000; Full time

Job summary

Regeneron is seeking a Senior Manager, GCP Quality Management - Global Development to lead risk-based quality management across global clinical trials in a hybrid work model. You will collaborate with study teams, CROs, and quality colleagues while supporting inspection readiness and continuous improvement across the organisation.

The role requires a Bachelor's degree and eight years of healthcare/pharmaceutical experience, plus strong knowledge of GCP, risk management, and regulatory

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

Communication

Collaboration

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

• 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

Salary Range (annually)

86,800.00 - 141,200.00

Does this sound like you?

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.

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.

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.

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.