Senior Director, Commercial Quality Abiomed (USA)

About the role

The overall purpose of this role is to lead multiple workstreams in support of the development and enhancement of 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 implementing 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 also manage the QA Director Japan and Senior Managers in both EMEA and APAC, focusing on priority elements including Field Action, Distributor Management, and Distribution Control.

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 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.
• Sets up 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.

Requirements

• This role requires a diverse business background, preferably with direct experience in multiple J&Johnson 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.

Skills

• 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.
• 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.
• Key feature of this role is the high degree of change management that will occur through the assignment.

Qualifications

• This role requires a diverse business background, preferably with direct experience in multiple J&Johnson 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.