Manager GCP Quality, Technology and Compliance

Were looking for a quality-minded systems expert to help shape how regulated processes are managed across Global Development.

As Manager GDQTC youll support our Veeva Quality Suite-based eQMS by overseeing how quality issues like deviations and CAPAs are captured escalated and resolved. Working across Clinical Regulatory and Medical Affairs teams youll ensure the eQMS continues to meet the needs of a complex fast-evolving environment. This role offers the opportunity to blend quality process ownership with system-level thinkingdriving meaningful improvements in how we maintain GCP and GVP compliance across Regenerons global development operations.

A Typical Day:

• Managing and triaging user requests via the Quality Support Mailbox

• Coordinating eQMS system upgrades and configuration changes with Global Development IT

• Supporting issue management workflows including deviations CAPAs investigations and change controls

• Gathering and refining business requirements to guide system enhancements

• Creating dashboards storyboards and reports for audit readiness and quality oversight

• Liaising with stakeholders across Clinical Regulatory Medical and Quality functions

• Ensuring adherence to SDLC principles and validation expectations for all system changes

• Identifying and driving process improvements tied to system use support and compliance

This Role May Be For You:

• Youve managed or owned quality workflowslike deviations and CAPAswithin an electronic QMS

• Youre adept at managing the full system lifecycle from implementing new features to overseeing data standards and vendor performance

• Youre familiar with the Veeva Quality Suite especially QualityDocs and QMS modules

• You bring hands-on experience with GCP and/or GVP-regulated processes

• Youre a strong communicator who enjoys cross-functional collaboration and stakeholder engagement

• You enjoy training supervising and mentoring junior staff

• You thrive in structured environments and bring rigor to how systems and data are handled

• Youve supported system changes under regulated SDLC practices (validation change control etc.)

• You enjoy working at the intersection of quality technology and operations

• Youre analytical and enjoy using data to inform decisions and improvements

To Be Considered:

Youll need a bachelors degree and at least 6 years of experience in the pharmaceutical or healthcare industry. The ideal candidate has supported quality issue management processessuch as deviations CAPAs and investigationswithin a GCP or GVP setting. Experience with the Veeva Quality Suite (especially QualityDocs and QMS modules) is strongly preferred and formal Veeva Vault Platform certifications (e.g. White/Gray Belt) are highly desirable. Familiarity with related clinical systems is a bonus.

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits which often include (depending on location) health and wellness programs fitness centers equity awards annual bonuses and paid time off for eligible employees at all levels!

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 nationality national or ethnic origin civil status age citizenship status membership of the Traveler community sexual orientation disability genetic information familial status marital or registered civil partnership status pregnancy or parental status gender identity gender reassignment military or veteran status or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment unless the accommodation would impose undue hardship on the operation of the Companys business.

For roles in which the hired candidate will be working in the U.S. the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S Japan or Canada please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity right to work educational qualifications etc.