Manager, Commercial Quality Global Labeling and IFU, DePuy Synthes

Job description

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: Professional All Job Posting Locations: Raynham, Massachusetts, United States of America, Remote (US) Job Description: We are searching for the best talent for Manager, Commercial Quality Global Labeling and IFU (Instructions for Use) to join our DePuy Synthes Quality & Compliance 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, Commercial Quality Global Labeling and IFU will lead end-to-end improvements of global labeling processes, spanning business-unit labeling practices, country-specific label design, application, and execution, to ensure compliance and operational excellence across Distribution Centers and third-party logistics partners. This role will influence and guide a team supporting regional supply chain labeling systems and Instructions for Use (IFUs), maintain audit readiness, and ensure compliance with emerging regulations for labeling customizations to protect the right to sell across all medical device businesses at the country level. This role will act as the strategic interface between Supply Chain, Deliver Functions, Regulatory Affairs, and Commercial Quality, providing day-to-day operational support and driving changes related to new product introductions, product transfers, and regional regulatory updates. Key Responsibilities Leads establishment of end-to-end processes and systems for Global Labeling, in partnership with Regulatory Affairs, Supply Chain, Q&C and Deliver functions, to ensure compliance of Medical Device products commercialized / distributed globally. Supports the sustainability of Right Stage Customization system & processes. Supports the sustainability of the Repack Relabel (RPRL) Power App. Supports the implementation and sustainability of the new global process for DePuy Synthes electronic IFU deployment. Serves a key point of contact and voice of Commercial Quality (DCs, LOCs) on the Right Stage Customization governance. Supports Deliver sites with troubleshooting and problem solving, facilitating investigations and connections with key stakeholders from the E2E process Monitors processes improvement and evolutions through NC, CAPA and Escalations trends, continuously improving the process based on trends & root causes identified. Develops, leverages, and implements forward thinking innovation strategies and capabilities related to this process, (such Advanced Analytics, Artificial Intelligence, digital product, and supply chain solution support) connected with the overall Digital QMS and E2E Integrated Data strategies. Maintains close connection with the regions to share improvements and trends related to this process, collect additional insights from key business partners and from customers, ensure new or emerging regulations are considered as part of processes enhancements and maintain global standardization approach. Executes activities under GxP and ensure ongoing audit readiness. Qualifications Education Bachelor’s degree required (Engineering, Life Sciences, Regulatory Affairs, or related field). Advanced degree (Master’s, MBA, or equivalent) preferred. Experience and Skills Required: 6+ years of experience in Quality, Regulatory Affairs, or Compliance within a medical device and/or regulated healthcare environment. Labeling and/or experience in last mile operations Strong planning, project management, risk management and change management expertise. Strong working knowledge of global medical device including labeling regulations and standards (e.g., FDA, EU MDR, ISO 13485). Process Excellence (Lean, six sigma) experience across diversified business areas or equivalent quality standards programs. Successfully executes work in a highly matrixed, cross functional, often ambiguous environment Experience with Microsoft Power Apps Demonstrated track record of process improvements, turnaround, and transformations. Excellent decision-making and problem-solving skills Team building, influencing, and development capabilities Preferred: Extensive experience in US Health Authority audits. Experience operating in a global, matrixed Orthopedics organization Track record of driving large‑scale process improvement and transformation initiatives. Familiarity with digital quality systems and data‑driven compliance monitoring. Excellent written and verbal communication skills, including interaction with regulatory authorities. Other Travel: Limited; Up to 25%, domestic and international. Certifications: ASQ, PMP, or similar certifications preferred but not required. Language: English required; additional languages a plus. 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 documentation required by state law to start the assignment, as well as get a parent’s consent for the background check. 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