drjobs Associate Director Inspection Management GCP

Associate Director Inspection Management GCP

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1 Vacancy
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Job Location drjobs

Basking Ridge, NJ - USA

Monthly Salary drjobs

$ 154800 - 252800

Vacancy

1 Vacancy

Job Description

The Associate Director Global Development Quality Inspection Management (GDQIM) acting as an Inspection Management Lead (IML) is a key position that is responsible for the effective management ofGCP GVP and GLP inspections. The GDQIM IML will engage with key stakeholders build strategicpartnerships working and liaising with Clinical Study teams relevant functions and other GDQ functionsto support teams with inspection preparation activities on all Regeneronsponsored clinical trials.

This is a hybrid position with 3 days onsite requirement.

In this role a typical day might include the following:

Ensuring and managing the notification of all relevant internal and external stakeholders of upcomingand/or anticipated regulatory inspections.
Ensuring the preparation management and integration of inspection management processes andtraining activities into the clinical development programs and all relevant stakeholders.
Providing effective guidance consultancy and support to the Clinical Study Teams (and any otherkey stakeholders) in advance of an impending inspection.
Assisting with the identification of opportunities to conduct mock inspections and/or Investigator SitePreparation Visits in collaboration with the GD Quality Assurance (GDQA) team and other relevantfunctional groups.
Identifying and discussing with the Clinical Study Teams potential issues and/or gaps in advance ofan impending inspection that may require strategies to mitigate risk and/or provide additionalclarification to an inspector.
Ensuring the preparation management and conduct of inspection preparation sessions which includemock inspections trainings and clinical site preparation visits working with GDQA team to identifyand mitigate risks to clinical programs.
Serving as the back room lead/colead or front room colead responsible for explaining managingand ensuring the of all activities including managing the tracking of requests and inquiriesand coordinating requests for responses from relevant personnel during any regulatory inspectionconducted worldwide.
Responsible for managing the preparation and provision of timely inspection updates and daily/endof inspection summaries to GD Executive and Senior Management in addition to any other keyrelevant internal and external stakeholders.
Responsible for managing inspection response development and Corrective Actions/PreventiveActions (CAPA) followup activities alongside other GDQIM colleagues crossfunctionalstakeholders and process owners.
Ensuring and managing the development collection reporting and analysis of inspectionrelatedquality data trends and metrics.

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.
Extensive 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 followup.
Effective management of interpersonal relationships stakeholder
engagement and collaborations.
Demonstrated ability to interface and collaborate effectively with other
Managers and Directors within and external to the organization.
Extensive experience in providing training and presenting information on
key quality and regulatory compliance information.

To be considered for this opportunity we are looking for:

Bachelors degree with a minimum of 10 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).
Experience in training supervising line management mentoring and
development of staff and leading a small team

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.

Salary Range (annually)

$154800.00 $252800.00

Required Experience:

Director

Employment Type

Full-Time

Company Industry

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