Capabilities Manager

Johnson & Johnson Innovative Medicine • Shepherdsville, KY

1d

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. Education: A Bachelors degree is required. A minimum of 4 years of experience is required. General Requirements: 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. This includes: 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 Temperature Control: 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/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. Document Control: 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. Licensing & Registration: She/He will be the subject matter expert in Facility, Business and Product Licensing and Registration. They will be 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. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : 102,000-173,400 Additional Description for Pay Transparency: Subject to the terms of their respective policies and date of hire, 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 Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits 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/. Do Not Sell or Share My Personal Information Limit the Use of My Personal Information

Requirements

• A Bachelors degree is required.
• A minimum of 4 years of experience is required.
• Possessing high-level multi-tasking and organizational skills

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.
• 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
• 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.
• 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

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees