Senior Director, Commercial Quality Abiomed (USA)

Overall Purpose of Job Due to significant growth, Abiomed is working to develop and enhance Commercial and Distribution capabilities globally, including Quality Operations support to these functions and integration with the J&J Delivery organization. The incumbent will lead multiple workstreams focused on implementing J&J standards compliance for commercial operations, 3PL logistics supplier quality, storage, distribution, kitting operations, product returns and material and product controls, with an unwavering focus on customer experience. Key Responsibilities Model Johnson & Johnson Credo behaviours, ensuring organisational compliance with the J&J Code of Business Conduct. Lead, develop and motivate the team using the J&J Five Conversations model. Partner with Abiomed Regulatory Affairs, Commercial and Distribution organisations to define customer priorities and quality plans. Define processes, systems, resources and SOPs in line with J&J policies, standards and applicable regulations. Own operational responsibility for Abiomed Commercial Quality execution across regions, coordinating with QA Director Japan and Senior Managers in EMEA and APAC. Connect with J&J Commercial Quality and Distribution organisations to leverage opportunities, share SME knowledge, best practices and cost‑improvement initiatives. Ensure compliant launch of the new Peabody facility, including quality plan execution, inspection management during Health Authority visits, audits, licensing and regulatory compliance. Review construction plans, risk assessments and qualification protocols, approving new facility risk assessments, process qualification protocols, results and reports. Establish a comprehensive suite of control documents (SOP/WI) for the new facility, improving upon existing Danvers documents. Ensure appropriate training plans to support compliant operations at the new facility. Monitor and assess the project quality plan performance via metrics, scorecards and reviews with Abiomed Quality and Operations. Identify and secure required resources to ensure project success. Special Requirements Expert technical knowledge in applicable regulations, quality systems and operations for medical device and/or pharmaceutical construction, qualification, manufacturing, commercial quality and distribution activities (inbound material inspection, labeling, kitting, storage, transportation) and a strong record of executing strategic initiatives through collaboration. Job Requirements Experience in positions of increasing responsibility within multi‑site global organisations, with broad quality management experience and extensive people‑management experience. Must be able to operate across multi‑cultural/multi‑country locations and healthcare regulatory requirements. Required Skills Build consensus and influence outcomes without line authority, negotiating trade‑off decisions across the organisation. Strong collaboration and influence skills to partner effectively across functions and operating units. Strong analytical and strategic skills with a bifocal approach – ability to zoom in and out for strategic, tactical, high‑level and detailed perspectives. Experience interfacing with global regulatory agencies (FDA, MHRA, TGA, notified bodies) and resolving complex regulatory compliance issues. Education Undergraduate degree in science, engineering, or a related scientific discipline. Master's degree in business, science, engineering or a related scientific discipline preferred. Core Competencies Decisive, organized, and able to lead people within a complex global environment. Excellent communication and presentation skills, inspiring trust and quickly building credibility within Quality, Compliance, Supply Chain and Commercial organisations. Hands‑on operational orientation focused on the customer. Accountable with a strong desire to commit and be rewarded for delivering results. Recognises and builds support for change, engaging in constructive conflict. High tolerance for ambiguity in a complex environment, making the complex clear and easily understood by others. Strong relationship development, conflict resolution and team‑building instincts, with the ability to build partnerships internally and externally. Fluent in English. Compensation & Benefits Base pay range: $178,000.00 – $307,050.00. Eligible for consolidated retirement plan, savings plan (401(k)) and long‑term incentive program. Time‑off benefits include vacation, sick, holiday, work‑personal‑family, parental, bereavement, caregiver, volunteer and military spouse time‑off. For additional general information on company benefits, see . Equal Opportunity 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. Johnson & Johnson actively seeks qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an inclusive interview process and accommodations for applicants with disabilities. #J-18808-Ljbffr 6942-ABIOMED Inc. Legal Entity