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Associate Director Inspection Readiness & Data Management

Company: Regeneron Pharmaceuticals, Inc.
Location: Basking Ridge
Posted on: November 26, 2022

Job Description:

Responsible and accountable for handling, advising and coordinating Inspection Readiness and CAPA Management activities within DM Operations. Lead the group to provide full support of HA inspections with enhanced regulatory awareness. Be the primary point person for all inspections involving the Data Management function, and ensure CAPAs are accurately drafted and closed.In this role, a typical day might include the following:

  • Establish and maintain a partnership relationship with GCP Compliance roles and customer-orientated approach within the DM Inspection Readiness and CAPA Management group
  • Responsible for proposing/defining internal DM quality-related metrics as well as ongoing collection and quarterly reporting of DM quality-related metrics including inspection-related metrics and governance of HA responses and CAPA fulfillment.
  • Coordinate with GCP Compliance to assess the portfolio for near, medium, and longer term likelihood of future DM-related inspection targets. Based on this info, use a risk-based approach to selectively perform internal quality reviews as well as prioritization of efforts to remediate any historical problems.This role may be for you if:
    • Support the improvement in quality within Data Management by proactively identifying and addressing areas of concerns from Health Authority inspection findings to avoid downstream issues.
    • Collaborates closely with Global Development functions, to ensure that CAPA fulfillment activities are defined, measured, handled and that findings are used to improve efficiency and quality of clinical trial collection, analysis, reporting and submission across the portfolio of studies.
    • Ensures adequate resources are in place to support all company inspections.
    • Accountable to ensure that findings from audits, inspections, and internal reviews, are strategically translated into positively framed useful feedback to drive improvement.To be considered you should have Bachelor degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree. At least 5 or more years of clinical data management operations or data management experience and proven track record in biotechnology, pharmaceutical or health related industry. Previous oncology and/or ophthalmology experience a plus.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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.Salary Range (annually) $145,200.00 - $237,000.00

Keywords: Regeneron Pharmaceuticals, Inc., Newark , Associate Director Inspection Readiness & Data Management, Executive , Basking Ridge, New Jersey

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