Company: Johnson & Johnson Location: Mooresville, IN Employment Type: Full Time Date Posted: 07/24/2021 Expire Date: 09/22/2021 Job Categories:
Accounting/Auditing, Advertising/Marketing/Public Relations, Biotechnology and Pharmaceutical, Computers, Software, Healthcare, Practitioner and Technician, Information Technology, Personal Care and Service, Sales, Transportation, Executive Management, Franchising, Quality Control, Research & Development, Medical
Manager of Distribution Quality and Compliance
Johnson & Johnson is recruiting for a Manager, Distribution Quality and Compliance to be located from Mooresville, IN.
Johnson & Johnson Consumer Inc., based in Skillman, N.J., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S® Baby, BAND-AID®, NEUTROGENA®, TYLENOL®, MOTRIN®, and LISTERINE®. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.
The Manager of Distribution Quality and Compliance provides oversight of the Quality Management Systems and its compliance to all applicable laws and regulations at the Distribution Center. Working closely with various internal and external partners you drive innovation within functional area while ensuring initiatives are delivered in a compliant and efficient manner.
Oversight of process and systems related with cGMPs, Product handling and storage, quality investigations and managing partnerships with 3PLs, Franchises and Affiliates. Serve as single point of contact to internal and external partners on Distribution Quality related matters to drive timely resolution of Quality related issues.
Must be a strong leader to support 24/7 operations of the Distribution Center who is continuously working to improve quality, cost and time factors, consistent with both Sector and Commercial Quality business objectives.
Responsible for Quality oversight to the receiving process within the DC as well as dis positioning of damaged packages (incoming) according to procedures or predefined agreements with Source co., Franchise, or Marketing Co. Responsible for Quality oversight in the followings: monitoring of product destruction process, quarantine/hold/stop-ship/recall processes within the DC and in pick/pack/and ship operations, including trending of pick/pack/ and ship errors.
Responsible for ensuring returned product is dispositioned according to procedures or predefined agreements with Source co., Franchise, or Marketing Co. Also responsible for approbation of rework or special inspection operations conducted within the DC.
Responsible for Quality Management of temperature-controlled facilities: responsible for ensuring compliance with monitoring of ambient environment (temperature and humidity as required) while maintaining oversight for the identification and communication of temperature excursions occurring within the DC to appropriate partner for the oversight for the investigation and subsequent remediation activities.
Responsible for Quality management input on the Warehouse Management Systems and oversight of records and document management and provide input to the development of validation, implementation, and changes of Cal/PM, CAPA, NC, IA, Doc Mgmt software systems.
Review and provide guidance to 3PLs on creation and revisions to their procedures to ensure alignment with J&J quality agreements, service contracts, and J&J procedures and policies.
Responsible for the oversight, management and processing of complaints reported to DC (OS&D Product and Service-related complaints) including tracking and trending.
Create, review, and approve assessment plans, risk assessment reports. Evaluate overall compliance risk, recommend corrective actions and monitor progress. Responsible for the execution of DC QSCAN risk evaluation. Makes quality decisions based upon assessments of compliance risks balanced with the overall business needs. Advance all appropriate issues to CQ Leadership
Responsible for conducting internal Quality audits of DCs (schedule, plan, conduct, and follow up). Responsible for oversight of DC facility licenses. Responsible for the co-management with 3PL of all Health Authority inspections (e.g. FDA) conducted at the DC, including reviewing the preparation plan with on-site management.
A Bachelor's degree is required, preferably in an Engineering, Life Sciences, or Technical field
6-8 years of proven experience in a highly regulated industry is required. QA/QC experience in the Medical Device, Pharmaceutical or Consumer products industry and experience with regulatory inspections is preferred.
Strong knowledge of FDA 21 CFR Part 820 and/or ISO 9001 and/or ISO 13485 and/or ERP systems is required.
Strong communication, collaboration, problem solving, decision-making, and root cause analysis skills are required.
Six Sigma, Lean, 5S or ASQ Certification and trainings are preferred. Experience with Warehouse Management Systems is preferred.
Experience with Temperature control Transportation is preferred.
This position is located in Mooresville IN and may require up to 20% domestic travel
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location United States-Indiana-Mooresville-9440 South State Road 9 Organization Johnson & Johnson Consumer Inc. (6101) Job Function Quality Requisition ID 2105951283W