Capabilities Manager

Johnson & Johnson•Shepherdsville, KY

About The Position

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: Supply Chain Deliver Job Sub Function: Warehouse & Distribution Job Category: Professional All Job Posting Locations: Shepherdsville, Kentucky, United States of America Job Description: Job Description 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. Learn more at https://www.jnj.com/innovative-medicine 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.

Requirements

A Bachelors degree is required.
A minimum of 4 years of experience is required.
Possessing high-level multi-tasking and organizational skills and being able to troubleshoot complex issues.

Responsibilities

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.
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
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/validating 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.
Leading and managing the Document Control Team.
Good Documentation Policies (GDP).
Ensure document retention rooms are audit ready, retention cycles are followed.
Facilitate the business in updating documents when requested.
Being the subject matter expert in Facility, Business and Product Licensing and Registration.
Responsible for 3rd party provider over our licensing.
Responsible for evaluation of 3rd party licensing provider to discover opportunities for improvement, reduced risk, and reduced cost.
Remaining compliant for Warehousing and Distribution.

Benefits

Employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours