Johnson & Johnson Innovative Medicine · 4 days ago
Capabilities Manager
Shepherdsville, KY
Full-time
Onsite
Mid Level
$102K/yr - $173K/yr
4+ years expJohnson & Johnson is a leader in healthcare innovation, dedicated to developing smarter and less invasive treatments. The Capabilities Manager will manage and develop work processes for compliant product and customer delivery requirements in the distribution operation, while also leading efforts in temperature control and document management.
Pharmaceuticals
Responsibilities
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
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
Good Documentation Policies (GDP)
Ensure document retention rooms are audit ready, retention cycles are followed
Facilitate the business in updating documents when requested
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
Qualification
Required
A Bachelors degree is required
A minimum of 4 years of experience is required
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
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
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
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
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