Manager, DM Inspection Readiness and CAPA Management

Job Description

Responsible and accountable for leading and performing Inspection Readiness and CAPA Management activities. Supports implementation of process improvements related to inspection readiness and/or as a consequence of CAPAs impacting DM. Works extensively with partner QA/GCP Compliance functions and relevant study teams to support audits and inspection preparations as well as responses for requests/questions during audits/inspections.

In this role, a typical day might include the following:

• Participate, as needed, in initiatives within Global Development.
• Lead study-level Inspection Readiness activities, build documentation for SOP Deviations and other Quality Events that occur within or impact DM.
• Perform and/or follow-up with co-workers performing DM-related CAPA actions to ensure timely completion.
• Provide mentorship to data managers when preparing for an audit, inspection, or handling a potential quality issue, advancing as/when needed.
• Assist in the performance of Root Cause Analysis and drafting of appropriate CAPAs.

This role may be for you if:

Establish and maintain a partnership relationship with relevant QA/GCP Compliance groups/roles that regularly interact with DM in connection with SOP Deviations, audits and inspection readiness and conduct, and CAPA Management.

Helps drive DM inspection readiness through proactive internal reviews, providing teams with support to resolve obstacles to process adherence and support for improvement of process training materials when gaps are identified

Support the improvement in quality within Data Management by proactively identifying and assisting in the efforts to address areas of concerns from Health Authority inspection findings.

Assist the Head of DM Inspection Readiness and CAPA Management as well as DM Leadership Team to drive a quality, compliance and quality process improvement within DM and neighboring functions.

To be considered We seek a Bachelor degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree. Must have least 5 or more years of clinical data management experience. Previous experience supporting audits and/ or inspections is a plus. Familiarity with applicable regulations including CFR, GCP, and ICH Guidelines.

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 parental 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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