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Regeneron

Temporary Quality Manager GCP - GVP

Posted 10 Days Ago
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Remote
Hiring Remotely in United States
Senior level
Remote
Hiring Remotely in United States
Senior level
Supports Global Development quality system governance, quality event oversight, metrics and trend reporting, root cause investigations, CAPA development, procedural reviews, and continuous improvement. The role collaborates with quality stakeholders, facilitates governance meetings, presents quality system data, supports regulatory inspections, delivers training, and provides subject matter expertise in GCP and GVP quality management.
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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 Temporary Quality Manager GCP - GVP, supporting our Global Development quality system in a remote work model. In this role, you will support quality management system governance, quality event oversight, and continuous improvement activities while collaborating with Global Development functions and quality leaders. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. This is a 12 month contract.

When & where:

UK, US, or Ireland

Work model: Remote

Discover your role:

  • Engage Global Development stakeholders to drive process improvements, standardization, and regulatory compliance.

  • Manage quality metrics and trend reporting to support continuous improvement.

  • Oversee the Quality Event portfolio and provide subject matter expertise to functional teams.

  • Lead quality data analysis, root cause investigations, and Corrective Action/Preventive Action development.

  • Manage Quality System Metrics, including thresholds, reporting, actions, and effectiveness measures.

  • Facilitate governance meetings and present data on Quality Management System health.

  • Coordinate procedural document reviews and impact assessments across GDQGO.

  • You promote quality culture and strengthen collaboration across Quality Management System elements.

This role requires:

  • Bachelor's degree and 6+ years of healthcare or pharmaceutical industry experience.

  • Experience in Quality Management, Quality Assurance, or Clinical Development roles with Good Clinical Practice and/or Good Pharmacovigilance Practice expertise.

  • Knowledge of Quality Management System oversight, governance, quality event management, and continuous improvement.

  • Experience as a subject matter expert, process owner, or business process owner in a quality-related area.

  • Experience delivering training and presenting quality and regulatory compliance information.

  • Experience supporting or participating in regulatory agency inspections.

  • Experience training, supervising, or mentoring staff.

  • Strong project management, prioritization, organization, and time management skills.

  • Strong communication, presentation, collaboration, and interpersonal relationship skills.

  • Ability to identify process gaps, manage multiple priorities, and apply sound judgment with integrity and attention to detail.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site 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.

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