Manager Quality Assurance

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Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Manager Quality Assurance.

This position can be located in New Jersey or Pennsylvania with a preference for Raritan, NJ.

Position Summary
The Manager, Quality Assurance provides leadership and oversight for specified external manufacturers of Advanced Therapy products, ensuring consistent delivery of pharmaceutical products from the external manufacturer that meet all required safety, regulatory compliance, and product quality standards.

The Manager leads people, influences stakeholders, and ensures sustained inspection readiness and regulatory compliance.

This position may lead a work team as needed, located on-site as well as remote, that is responsible for delivering the site quality goals.

Position may require up to 30% travel.

Key Responsibilities


* Lead and oversee quality systems, processes, and controls to ensure effective and compliant execution of quality systems at external manufacturing sites.


* Manage quality oversight in the selection, qualification, and ongoing monitoring of external partners.


* Lead the identification and resolution of quality issues and complaints, including facilitation of investigation process and development of robust CAPA plans.


* Review and approve quality systems documentation, including product disposition, manufacturing instructions, change controls, specifications, validation documentation, and technical studies.


* Analyze quality metrics and trends to proactively identify risks and opportunities for improvement.


* Build relationships with internal and external partners; influence external manufacturers to continuously improve processes and procedures passionate about reliability, execution, and quality culture.


* Collaborate with External Manufacturers to support health authority inspections inclusive of follow-up on associated responses and...