Senior Director, Commercial Quality Abiomed

The incumbent will be responsible for leading multiple workstreams in support of this development activity, focused on implementation of J&J standards compliance for commercial operations, 3PL logistics supplier quality, storage, distribution and transportation, kitting operations, product returns and material and product controls. The incumbent will recommend and drive implementation of compliant, fit for purpose controls on these activities globally, with an unwavering focus on customer experience. The incumbent will be operationally responsible for Abiomed Commercial Quality execution in the regions, managing the QA Director Japan and Senior Managers in both EMEA and APAC, and focusing on priority elements including Field Action, Distributor Management and Distribution Control. The incumbent will represent Quality on the Project Leadership team and is the Directly Responsible Individual for Quality, fully accountable to deliver the project on-time, on-budget and in full compliance with quality plans and regulatory or other defined requirements. Models Johnson & Johnson Credo behaviors and decision making and ensures organizational compliance to the Johnson & Johnson Code of Business Conduct. Manages, develops, and motivates team using the J&J five conversations model. Identifies high potential talent, mentors, and advocates for that talent, and works proactively to accelerate development. Drives a proactive and accountable culture of Inclusion. Partners with the Abiomed Regulatory Affairs, Commercial and Distribution organizations to define customer priorities and quality plans to achieve customer requirements, support growth and ensure compliant commercial and distribution operations in all global markets. Defines in collaboration with the Operations and Quality representatives of Abiomed, processes, systems, resources, and SOPs, for the organization in line with the J&J policies, J&J standards, and applicable regulations. Owns operational responsibility for Abiomed Commercial Quality execution in the regions. Connects the Abiomed organization to the broader J&J Commercial Quality and Distribution organizations to identify leveraging opportunities, SME knowledge, best practices, and cost improvement opportunities. Drives a collaborative approach for integration of Abiomed into the J&J family. Accountable for ensuring compliant startup of new Peabody facility operations via execution of the quality plan, including inspection management during Health Authority visits and ERC or internal audits. Ensures necessary site licensing and certification activities are completed in cooperation with Regulatory Affairs, inclusive of US FDA registration, Notified Body certification and State Board for Pharmacy distribution license. Reviews construction plans and design documents to ensure compliance to requirements. Identifies outside support resources for qualification activities. Reviews, and approves (as applicable) new facility risk assessments and process qualification protocols, results, and final reports. Ensures a comprehensive suite of controls documents (SOP/WI) for the new facility is established, leveraging and improving upon existing documents from the Danvers site. Scope to be inclusive of, but not limited to facility cleaning and maintenance, pest control, calibration, temperature control and monitoring, kitting/packaging operations, labeling control, material control, returned product control, recalled product control, shipping, distribution, indirect material supplier purchasing controls and internal audit. Ensures appropriate personnel training is planned and achieved to support compliant operations at the new facility. Establishes programs to effectively monitor and assess the performance of the project quality plan through metrics, scorecards, and review with Abiomed Quality and Operations. Identifies resource needs to ensure project success.

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.

• This role requires a diverse business background, preferably with direct experience in multiple J&J segments and Corporate, with specific quality, regulatory and regulatory compliance competencies in the areas of GP facility construction and qualification, MedTech manufacturing, supplier quality, storage, and distribution.

• Experience in positions of increasing responsibility supporting large, multi-site, global organizations, with broadly based quality management experience and extensive people management experience.

• Experience with the global demands of the role specifically: multi-cultural / multi-country locations and healthcare regulatory requirements.