SR Risk Management Specialist

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 Systems

Job Category:
Professional

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

Job Description:

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies is recruiting for a Senior Risk Management Specialist! This position will be located in Raritan, NJ.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.

Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us We bring together the best minds and pursue the most promising science.

We are Janssen.

We collaborate with the world for the health of everyone in it.

Learn more at www.janssen.com and follow us @JanssenGlobal.

Janssen Pharmaceuticals, Inc.

is part of the Janssen Pharmaceutical Companies.

Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy.

This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity!

The Sr.

Risk Management Specialist will support Risk Evaluation and Mitigation Strategies (REMS) and general risk management activities for the Raritan, NJ Advance Therapies (AT) site.

Key Responsibilities:


* Develop and support risk assessments for the Raritan manufacturing site.


* Assist and lead development of and updates to SOPs and technical documents.


* Assist in developing and maintaining robust metrics and measure for risk management program.


* Support audits and inspections readiness and participate in site inspections and audits from internal and external regulatory agencies.


* Assist in developing and maintaining robust risk management program and compliance documentation.


* Other duties will be assigned, as needed.

Qualifications

Education:


* Minimum of a Bachelor’s or equivalent University degree is required.

Experience and Skills:

Required:


* Minimum four (4)...