Regeneron Pharmaceuticals Senior Manager, GD Quality Improvement in Tarrytown, New York
The Regeneron GCP Quality Improvement Manager will work with GCP Quality Improvement team to ensure that Regeneron Global Clinical Development Processes and Procedures are followed, and that any Process Deviations are investigated and documented with the Quality Management System. The GCP Quality Improvement Manager will also manage Corrective or Preventive Actions (CAPA) within the Quality Management System. They will partner with other members of the GCP Quality group to identify trends through metrics in order to diagnose and remediate systemic quality issues, and will serve as a core member of Continuous Improvement initiatives.
In this role, a typical day might include the following:
Liase with GCP Compliance & Process Teams to proactively identify opportunities to streamline and strengthen GCP processes
Serves as GCP SME when SOPs are written or revised
Manage Quality Events and Actions (Process Deviations, CAPA) within regulated Quality Management System
Represent GCP expertise on cross-functional teams for GCP related process improvements resulting from new/revised regulations or guidance
Leads cross-functional rapid response teams for identified GCP process violations needing immediate remediation
Work closely with Regulatory Intelligence team to identify changes in global regulations affecting current Regeneron processes as they relate to GCP
Interfaces: SOP & Process team; GCP Inspection teams;functional process owners, and process improvement leads
Committees: ad hoc member of GCP Quality Forum
This role might be for you if:
- >5 years’ experience working in either a clinical compliance group,
QA Quality Management/Quality Risk Management function, or
Clinical Development with expertise and/or transferrable skills with
Good Clinical Practice and Regulatory Inspections.
- Demonstrated experience and leadership on Continuous
Improvement or Quality Improvement efforts (GCP Quality
- Demonstrated Quality Management System experience (GCP
specific QMS experience preferred)
- Demonstrated Issue Management and CAPA experience in a clinical
- Excellent communication skills and ability to work with people in
all levels of the organization and externally.
Demonstrated skills in taking initiative and working independently
Experience with FDA or other Regulatory Inspections of
Investigator sites, Sponsors or CROs.
- Self-motivated with the ability to work effectively in a dynamic
- Strong leadership with demonstrated ability to interface with senior
leaders and different levels of the organization
Good problem solving, written and verbal communication skills
Ability to effectively manage multiple priorities with a sense of
- Strong track record of project management, stakeholder
management, collaboration skills and negotiation of complex
- Attention to detail and accuracy of work
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
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