Senior Manager, Inspection Management

BioSpace; Armonk (NY); On-site; USD 132,400 - 216,000; Full time

Benefits offered by this job

Health and wellness programs

Fitness centers

Annual bonuses

Paid time off

Job summary

A leading healthcare company in Armonk is seeking a Senior Manager, Inspection Management. This role involves managing regulatory inspections and supporting Clinical Study Teams. The ideal candidate should have significant experience in GCP and GVP guidelines, along with a bachelor's degree and at least 8 years of relevant industry experience. The company offers a diverse culture and comprehensive benefits.

Qualifications

• Minimum of 8 years of relevant healthcare/pharmaceutical industry experience.
• Experience in a quality/compliance role or Clinical Development role.

Responsibilities

• Manage GCP, GVP and GLP inspections.
• Coordinate inspection preparation activities.
• Provide support to Clinical Study Teams before inspections.

Skills

Advanced knowledge of GCP and GVP guidelines

Experience with Regulatory Agency Inspections

Risk-based approaches to quality management

Education

Bachelor's degree

Job description

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The Senior Manager will support the Inspection Management Leads (IMLs) with the effective management of GCP, GVP and GLP inspections. The Senior Manager will engage with key stakeholders, build strategic partnerships working and liaising with Clinical Study teams, relevant functions and other Quality functions to support teams with inspection preparation activities on all Regeneron-sponsored clinical trials.

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

• Ensuring and responsible for the notification of all relevant internal and external stakeholders of upcoming and/or anticipated regulatory inspections.
• Working with Inspection Management Leads (IMLs) in preparing, managing, and integrating inspection management processes and training activities into the clinical development programs and all relevant stakeholders.
• Working with the IMLs in providing effective guidance, consultancy, and support to the Clinical Study Teams (and any other key stakeholders) in advance of an impending inspection.
• Working with the IMLs in identifying and discussing with the Clinical Study Teams potential issues and/or gaps, in advance of an impending inspection, that may require strategies to mitigate risk and/or provide additional clarification to an inspector.
• Working with the IMLs in preparing, managing, and conducting inspection preparation sessions which include mock inspections, trainings, and clinical site preparation visits.
• Supporting the front/back room lead/co-lead, by tracking requests and inquiries, coordinating/communicating requests for responses, and collecting responses from relevant personnel during any regulatory inspection conducted worldwide.
• Working with the IMLs in the preparation and provision of timely inspection updates and daily/end of inspection summaries to GD Executive and Senior Management, in addition to any other key relevant internal and external stakeholders.
  
  
  

This Role May Be For You If Have

• Advanced knowledge, understanding and application of GCP, and/or GVP guidelines including the management of significant/complex quality issues and compliance activities.
• Comprehensive experience with participating in, and supporting, Regulatory Agency Inspections of Investigator Sites, Sponsors and Clinical Research Organizations (CROs) in a GxP environment, including inspection preparation, facilitation, and follow-up.
• Experience in providing training and presenting information on key quality and regulatory compliance information.
• Advanced knowledge and application of risk-based approaches to quality management and oversight, building fit-for-purpose quality processes in partnership with cross-functional teams and leaders.
  
  
  

To be considered for this opportunity we are looking for:

• Bachelor's degree with a minimum of 8 years of relevant healthcare/pharmaceutical industry experience.
• Experience working in either a quality/compliance role (e.g., Quality Management, Quality Assurance etc.), or in a Clinical Development role with expertise and/or transferable skills related to Good Clinical Practice (GCP), and/or Good Pharmacovigilance Practice (GVP).
  
  
  

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 Company's 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.

Salary Range (annually)

$132,400.00 - $216,000.00

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Internet News

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