Sr Specialist, Clinical Risk Management

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Job Function:
Quality

Job Sub Function:
Clinical Quality

Job Category:
Professional

All Job Posting Locations:
Irvine, California, United States of America, Jacksonville, Florida, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Senior Specialist, Clinical Quality Risk Management! This position can be located in Irvine, California or Jacksonville, FL

Position Summary:

The Sr.

Specialist, Clinical Quality Risk Management works to support the Clinical Quality Risk Management (CQRM) objectives, overseeing a robust GxP Quality Management System to enable a diverse portfolio of medical device products and services.

This individual serves as the clinical quality point of contact to support clinical trial risk assessments, Integrated Quality Plans (IQP), risk mitigations, inspections, and provide guidance to ensure compliance with Good Clinical Practices (GCP), external regulations/requirements, and internal J&J Vision procedures.

The Manager is a subject matter expert and acts as a contact for Clinical Research & Development (R&D) functions to internal stakeholders and business partners.

Key Responsibilities:

The scope of responsibilities for the position will be applicable to the J&J Vision business, which includes J&J Vision Care and J&J Surgical Vision.
Clinical Portfolio Oversight


* Function as a subject matter authority for GCP for J&J Vision and be responsible for supporting, or leading as assigned, quality initiatives.


* Serve as a clinical quality point of contact for inspections, IQP and clinical study / program compliance concerns / escalation.


* Provide clinical quality oversight to clinical business partners to ensure compliance • with applicable GCP regulatory requirements, J&J Standards, and applicable J&J Vision SOPs.

Risk Management & Governance


* Establish routine presentation of compliance trends and metrics to business partners and help champion organizational performance and improvements measures.


* Develop and manage proactive risk management strategies in coordination with R&D leaders.


* Serve as a subject matter expert for Good Clinical Practi...