Senior Director, Commercial Quality

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 Deliver organization.
• 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 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.
• 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.

Requirements

• Expert level technical knowledge in applicable regulations, quality systems and operations for medical device and/or pharmaceutical construction, qualification, manufacturing, commercial quality, and distribution activities including inbound material inspection, mix-up prevention, labeling and kitting, storage, and transportation.
• A motivated leader who is passionate about coaching and leading high performing teams; and has a strong record of accomplishment for successfully executing strategic initiatives through collaboration with key stakeholders to bring measurable and significant impact to the organization.
• 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.