Director, Commercial Quality - Americas

• 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.

• 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 collaboration and influence leadership skills to partner optimally across functions and operating units preferred.
• Strong analytical and strategic skills with a bifocal approach - ability to zoom-in/zoom-out for strategic and tactical, high-level, and detailed preferred.
• Decisive, organized, and able to lead people within a complex global environment.
• Excellent communication / presentation skills, able to inspire trust and quickly build credibility within the Quality & Compliance and Commercial organizations.
• "Hands-on" orientation focused on the customer. Accountability, with a desire to commit, and be rewarded for delivering results. Recognizes and builds support for change.
• High tolerance for ambiguity in a complex environment. Makes the complex clear and easily understood by others.
• Strong relationship development, conflict resolution, and team building instincts, with the ability to build partnerships both internally and externally. Engages in open and honest communications.
• Fluent in English. Additional LATAM language capability is a plus.
• Regional and Global travel up to 20%.

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 and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.