Director, Commercial Quality - Americas

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: Danvers, Massachusetts, United States of America Job Description: We are searching for the best talent for a Director, Commercial Quality - Americas to be based in Danvers, MA. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Purpose: The individual will lead the Commercial Quality function focused on compliance for Americas commercial operations, field action execution, Commercial and 3PL logistics supplier quality, and supplier quality management for distributors. The incumbent will recommend and drive implementation of compliant, fit for purpose controls on these activities, with an unwavering focus on customer experience. You will be responsible for: Partners with the Abiomed Americas Commercial and Customer Service organizations to define customer priorities and quality plans to achieve customer requirements, and support growth and market expansion. Implements aligned processes and procedures at Abiomed to ensure compliant, efficient, and effective Commercial Quality operations supporting the growth forecast for the Abiomed business. Supports the Americas Commercial organizations and leadership teams as the key Quality partner to resolve quality related issues and guide business decision making through a quality lens. Responsible for all Quality lifecycle aspects of the distributor network in the Americas including qualification, audit, Quality Agreement and disengagement. Supports distributor compliance through negotiation, relationship management and enforcement of regulations and quality agreement requirements. Owns the field action process execution oversight responsibility for the Americas region including correction implementation reporting. Responsible for customer/distributor field action communications outside of the United States. Interacts directly with government health authorities and notified bodies in support of audit and field action execution, inclusive of US FDA, Health Canada, ANVISA, COFEPRIS and others. Support Quality responsibilities including SOP approval, Change Control and CAPA/Non-Conformance management for Customer Service, Commercial Operations, Clinical Sales Training, Medical Affairs, Marketing and Platform Operations and others as required. Responsible for the Commercial Supplier Quality management program within the Americas region, inclusive of suppliers for marketing and promotional materials, transportation, and field action support. Connects the Abiomed organization to the broader J&J Quality and Compliance organizations to identify efficiency opportunities, SME knowledge, standard methodologies, and cost improvement opportunities. Ensures appropriate personnel training is planned and achieved to support compliant operations within commercial quality. Other activities as required by management. Qualifications/Requirements: Undergraduate degree in science, engineering, or a related scientific field. Master's degree in business, science, engineering, or a related scientific field preferred. This role requires a diverse business background, with specific quality, regulatory and regulatory compliance competencies in the areas of commercial quality, supplier quality, distribution and customer service. Experience in positions of growing responsibility supporting large, multi-site, global organizations, with broadly based quality management experience. Experience with the global demands of the role specifically: multi-cultural / multi-country locations and healthcare regulatory requirements. Previous experience working with global regulatory agencies, e.g., US FDA, Health Canada, COFEPRIS, ANVISA supporting higher risk product classifications. Builds consensus and impacts outcome without always having line authority and can achieve trade off decisions across the organization. Must have strong collabor #J-18808-Ljbffr Johnson Johnson