Capabilities Manager

Johnson & Johnson Innovative Medicine•Shepherdsville, KY

1d•Onsite

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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About Johnson & Johnson Innovative Medicine: Our expertise in Innovative Medicine is 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 for a Capabilities Manager position based in Shepherdsville Kentucky. General Requirements: 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 be 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: 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. Document Control: Lead and Manage the Document Control Team Ensure Good Documentation Policies (GDP) are followed. Ensure document retention rooms are audit ready, retention cycles are followed. Facilitate the business in updating documents when requested. Licensing & Registration: Being the subject matter expert on Facility, Business and Product Licensing and Registration. Be the single point of contact that manages our 3rd party provider over our licensing. Continuously evaluate our 3rd party licensing provider to discover opportunities for improvement, reduced risk, and reduced cost. Remain compliant for Warehousing and Distribution Distribution Capabilities: As the business requires lead initiatives to develop compliant solutions for the storage and distribution of product for JOM. Under the team of “Distribution Capabilities” create a center of excellence in which this team is looked to as the Subject Matter Experts for all things distribution related. Benchmark internally and externally to remain best in class distribution organization. This is intended to be a general job description and should not be construed as all inclusive.

Requirements

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 be 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/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.
Lead and Manage the Document Control Team
Ensure Good Documentation Policies (GDP) are followed.
Ensure document retention rooms are audit ready, retention cycles are followed.
Facilitate the business in updating documents when requested.
Being the subject matter expert on Facility, Business and Product Licensing and Registration.
Be the single point of contact that manages our 3rd party provider over our licensing.
Continuously evaluate our 3rd party licensing provider to discover opportunities for improvement, reduced risk, and reduced cost.
Remain compliant for Warehousing and Distribution
As the business requires lead initiatives to develop compliant solutions for the storage and distribution of product for JOM.
Under the team of “Distribution Capabilities” create a center of excellence in which this team is looked to as the Subject Matter Experts for all things distribution related.
Benchmark internally and externally to remain best in class distribution organization.

Nice To Haves

Collaborating
Compliance Management
Cost Management
Demand Forecasting
Developing Others
Distribution Management
Distribution Resource Planning (DRP)
Fact-Based Decision Making
Inclusive Leadership
Inventory Optimization
Leadership
Operations Management
Order Management
Organizing
Program Management
Strategic Supply Chain Management
Team Management
Transportation Management
Warehouse Management

Responsibilities

Temperature Control: Acts as a single point of contact for JOM providing leadership and direction to supporting areas (i.e., Tech Op’s, Temp CoE etc.) for concept and design changes to temperature sensitive delivery systems and materials for JOM facilities.
Develops business case and cost/benefit analyses for management team to facilitate sound business decision-making.
Establishes working relationships with key temperature sensitive strategic vendors to identify and be well-informed of new innovative product delivery systems, services to meet product and market strategies.
Accountable to oversee all deviations, CAPA’s and closures related to temperature excursions that are attributed to a transportation carrier or related to the facility and/or equipment.
Has a broad understanding of the impact of facility changes on surrounding temperature controls.
Initiates change controls to manage changes within the distribution center.
Responsible for all related deviations, CAPA’s and closures related to cooler design (passive shipping solution, etc.)
Accountable for partnering with End to End Integration to provide leadership to represent Operations for all new product launches and or legacy product changes that require temperature controls.
Accountable for Trailer & Lane Mapping including a new carrier onboarding or remapping activities.
Accountable for any new JOM cooler qualifications or leveraging an existing cooler for commercial products
Responsible for Implementing/Leveraging existing coolers for the Clinical business
Responsible for periodic facility temp mapping, equipment requalification and temperature related equipment upgrades/installation
Responsible for maintaining Validation Master Plan (VMP)
Licensing: Ensure JOM remains compliant with all US Registration & Licensing Requirements.
Accountable to oversee all deviations, CAPA’s and closures related to temperature excursions that are attributed to licensing & registration
Facilitate New Product Launches by End to End Integration team for new product registration & distribution
Grow the licensing expertise in JOM to be Janssen wide.
Provides specific technical expertise to support special projects, product/process improvements; and provides input to develop capital expense forecast to support business needs.
Develops future capabilities for the business as required/related to Temperature/Licensing/Operational
Identifies, directs and implements potential cost savings and project execution improvements.
The successful Candidate will lead and directly manage a team consisting of Distribution Operations Analyst, Document Control Specialist & Distribution Capability Specialists.
The will liaise with individuals and units within or outside his/her organization, with responsibility for acting independently on technical or business matters pertaining to his/her field.
Need to have the ability to influence, and bring together, surrounding organizations that support temperature, facility, quality, and procedural initiatives.
Perform other related duties as required.
Works independently on routine and non-routine tasks.
Serves as subject matter expert within functional area.
Thinks analytically and acts decisively.
Is technically competent within job function.