Senior Director, Commercial Quality Abiomed (USA)

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:

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).

• USA Location Req#: R-086243

• Germany/Belgium/Ireland Location Req#: R-086336

• Switzerland Req#: R-086846

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 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 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. (~65% FTE)

Abiomed is also expanding manufacturing capacity and office space by relocating certain Abiomed operations from Abiomed Danvers MA to a newly leased facility in Peabody, MA. This role manages the quality aspects of this approved capital project. The specific operations to be relocated include:

• Material Receiving

• Inbound Material Inspection

• Post Sterile Inspection

• Field Service

• Inbound/WIP/Finished Goods Handling, Storage and outbound shipping and distribution

• Product Returns, including complaint samples and recalled products Pick to order (PTO) Finished Goods Kitting (assembly, labeling, release)

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.

Responsibilities:

• 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