Capabilities Manager

Capabilities Manager role at Johnson & Johnson Innovative Medicine

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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 Med Tech, 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

Supply Chain Deliver

Warehouse & Distribution

Professional

Shepherdsville, Kentucky, United States of America

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science‑based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

We are searching for the best talent,
Capabilities Manager

This position can be based in Shepherdsville, Kentucky or Somerset, New Jersey.

The JOM Franklin Distribution Center (FDC) is a 127,000+ sq. ft. distribution operation encompassing 30+ salaried and wage‑associated across 1 shift/5 days per week (occasional weekends) and includes both domestic and international logistics activities supporting 3 business areas:
Commercial, Clinicals and Sales & Marketing.

The JOM Kentucky Distribution Center (KDC) is a 322,000+ sq. ft. distribution operation encompassing 60+ salaried and wage‑associated across 1 shift/5 days per week (occasional weekends) and includes both domestic and international logistics activities supporting 2 business areas:
Commercial & Repack Operations.

A Bachelors degree is required.

A minimum of 4 years of experience is required.

The successful candidate will be responsible for managing and developing work processes that integrate compliant product and customer delivery requirements into the distribution operation for J&J customers.

• Promoting the use of Process Excellence tools for continuous improvement and cost savings programs/strategies to meet business requirements.
• Possessing high‑level multi‑tasking and organizational skills and being able to troubleshoot complex issues.
• Communicate to distribution and quality management in accordance with the event notification quality procedure.
• Interact with Regulatory Health Authority representatives during inspections as required and support responses to Regulatory Health Authorities.

This includes being the subject matter expert on methods of temperature‑sensitive distribution, production/distribution processes, and cGMP’s.

• Communicate and partner with the Global Temperature Control Systems Services Team (TCSS) on local/regional/global changes to Temperature Control standards and processes.
• Accountable for site qualification and validation programs for facility, equipment utilizing Quality Risk Management tools and associated documents.
• Responsible to review/qualify/validate temperature systems related to product storage and shipping (example: Cold Boxes, Passive Shipping solutions, Active Shipping solutions, etc.).
• Responsible for shipping and storage capability analysis for new product launches with regards to Product Stability Ranges.
• Develop new Temperature Capabilities as the business requires.

In addition, this person will be responsible for leading and managing the Document Control Team. She/He will be responsible for.

• Good Documentation Policies (GDP).
• Ensure document retention rooms are audit ready, retention cycles are followed.
• Facilitate the business in updating documents when requested.

She/He will be the subject matter expert in Facility, Business…