Manager, Serious Breach Office

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Job Function:
Quality

Job Sub Function:
Clinical Quality

Job Category:
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Issy-les-Moulineaux, France

Job Description:

Johnson & Johnson is currently recruiting for a Manager, Serious Breach Office.

This position can be located in North America or EMEA regions with a preference for Raritan, Titusville or New Brunswick, NJ and Horsham, PA.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.

While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
North America- Requisition #R-093180
EMEA- Requisition#

Position Summary:

The Serious Breach Office (SBO), Manager is a member of the Clinical Risk Management-Operational Excellence (CRM-OpEx) function of R&D Quality (RDQ).

This role provides JJIM awareness, facilitation and alignment of the processes that enable compliance to the country and regional level serious breach reporting requirements for JJIM sponsored clinical trials.

The incumbent will drive accountability in the implementation of the RDQ serious breach reporting process under the guidance of the SBO management and in collaboration with contributing business partners.

Through the coordination and consultation of stakeholder business partners, the SBO Manager will facilitate the assessment of significant quality issues related to JJIM sponsored clinical trials for reportability to serious breach reporting countries and/or regions.

Main Responsibilities:

• Serious Breach Office (SBO): As a facilitator of the serious breach process and record owner, you will drive the assessments and reporting of issues or events related to JJIM clinical trials that meet the serious breach reporting criteria to the appropriate corresponding Health Authorities.

You will be a member of a team designated as the primary subject matter experts for the JJIM organization to ensure compliance, effectiveness, and continual improvement of the seri...