Manager, US Field Inventory Commercial Quality

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. Job Function: Quality Job Sub Function: Customer/Commercial Quality Job Category: People Leader All Job Posting Locations: Bridgewater, Massachusetts, United States of America, Mooresville, Indiana, United States of America, Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America Job Description: We are searching for the best talent for Manager, US Field Inventory Commercial Quality to join our DePuy Synthes Quality organization located in the United States. This is a remote role available in all states within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. About Orthopaedics Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech The Manager, US Field Inventory Commercial Quality is responsible for the oversight and execution of Quality and Compliance programs within the US Depuy Synthes Commercial Quality Region for last mile operations supporting loaner and field inventory activities. These facilities include Field Sales Network Locations (Orthopedic Last Mile Operations) which are managed by Depuy Synthes. This position provides oversight and guidance on quality & compliance related matters, partners with Commercial Operations and Deliver on orthopedic field inventory and loaner program related matters, liaises with Franchise Quality, Microbiological Quality and Sterility Assurance, and Commercial Quality partners to drive resolution of quality related issues. Key Responsibilities: Where applicable, ensure Depuy Synthes Commercial Quality compliance to the Inter-Company Quality Agreement (ICQA) or legal contracts, including but not limited to: Audit and Inspection Management, Field Actions, Management Review, Purchasing Controls, Delivery Service Incidents, Product Quarantines, Holds, Recalls, Material and Product Controls. Where applicable, ensure compliance to the Quality Agreement (QAA), including but not limited to, Field Inventory standard, Inspection instructions, Regulatory Compliance, Change Control, Supplier monitoring, Quality Event Management, Non-Conformance, CAPA, Storage, Handling and Distribution, Product Returns and Disposal. Oversight of process and systems related with cGMPs, storage handling and distribution, quality investigations and managing partnerships with Franchises, 3PL and partners. Serve as single point of contact to internal and external partners on distribution quality related matters and liaise with other quality organizations to drive timely resolution of quality related issues. Create, review and approve assessment plans, risk assessment reports, non-conformance reports, corrective and preventive actions, audits, and other documentation. Support leadership and compliance activities including, but not limited to the creation and revisions of global and local procedures. Evaluate overall compliance risk, recommend corrective actions and track progress. Serve as Quality representative on project teams. Escalate all appropriate issues according to policy and report regional metrics as required. Perform managerial responsibilities in accordance with the organization's policies and applicable laws, including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; addressing complaints; and, resolving problems. Responsible for the overall direction, coordination, structure, and evaluation of employees. Manage or collaborate with employees in the areas of people development, skill development and career development Qualifications: 6-8 years of relevant experience working in a highly matrixed organization is required . A minimum of a Bachelor’s degree is required. Demonstrated ability to manage critical audits Ability to build consensus and lead individuals through change; strong project management experience Excellent communication skills and strong collaboration skills; partner effectively across functions Ability to make the complex clear and easily understood by others Flexibility to work independently and on teams and has excellent time management skills to handle multiple projects and deadlines. Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other d