Director External Quality, Advanced Therapies

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
People Leader

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

Job Description:

Johnson & Johnson is currently recruiting for a Director, External Quality-Advanced Therapies! This position can be located in Horsham, PA, Raritan, NJ or Maryland.

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress.

As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good.

We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.

Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

Position Summary:

This position provides Quality Assurance, Quality Control, Compliance and Quality Management oversight for the tech transfer process, clinical and commercial readiness for the BiCAR CMO, based in North America.

The role will report to the EQ Advanced Therapies Sr.

Director.

This role provides strategic direction, leadership and coordination of the different quality functions interacting with the CMO: ECSQ, EQ, JJRC, PQI, ATQ.

The role will represent quality in site readiness meetings and will ensure alignment to the CMC/VMT councils.

This role acts as Single Point of Contact for all Quality matters towards the CMO with the intention to ensure that all Quality related matters are ready for commercial manufacturing readiness as per program milestones.

The incumbent is accountable to escalate issues to Quality Sr leaders as appropriate.

This position provides leadership and management to a group of professionals that have the quality oversight of supply chain activities and execution of quality systems in support of drug product manufacturing for cell therapy clinical and commercial products.

The position holder works closely with other Quality functions, Technical Support, IT and Operations at the CMO.

He/she will ensure an aligned quality oversight of tech transfer, inspection readiness and supply chain activities, in support of the clinical and commercial readiness of the CMO.

Key Responsibilities:



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