Senior Director, Commercial Quality Abiomed (CH)

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 operations from Danvers, MA to a newly leased facility in Peabody, MA.

This role manages the quality aspects of this approved capital project, ensuring on‑time, on‑budget delivery and full compliance with quality plans and regulatory or other defined requirements.

Responsibilities

• Model Johnson & Johnson Credo behaviors and decision making and ensure organizational compliance to the Johnson & Johnson Code of Business Conduct.
• Manage, develop, and motivate team using the J&J five conversations model.
• Identify high‑potential talent, mentor and advocate for that talent, and accelerate development.
• Drive a proactive and accountable culture of inclusion.
• Partner with 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.
• Define processes, systems, resources, and SOPs in collaboration with Operations and Quality representatives of Abiomed, in line with J&J policies, J&J standards, and applicable regulations.
• Own operational responsibility for Abiomed Commercial Quality execution in the regions.
• Connect 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.
• Drive a collaborative approach for integration of Abiomed into the J&J family.
• Ensure 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.
• Ensure 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.
• Review construction plans and design documents to ensure compliance to requirements.
• Identify outside support resources for qualification activities.
• Review, approve (as applicable) new facility risk assessments and process qualification protocols, results, and final reports.
• Ensure a comprehensive suite of controls documents (SOP/WI) for the new facility is established, leveraging and improving upon existing documents from the Danvers site.
• Establish programs to effectively monitor and assess the performance of the project quality plan through metrics, scorecards, and review with Abiomed Quality and Operations.
• Identify resource needs to ensure project success.
• Job Requirements

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, Med Tech 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.

• Required Skills
• Builds consensus and impacts outcomes without always having line authority and can negotiate trade‑off decisions across the organization.
• Strong collaboration and influence management skills to partner effectively across functions and operating units.
• Strong analytical and strategic skills with a bifocal approach – ability to zoom in/zoom out for strategic and tactical, high‑level, and detailed.
• Previous experience interfacing with global regulatory agencies (e. g., FDA, MHRA, TGA, notified bodies) and a history of success and credibility resolving complex regulatory compliance issues.
• Hands‑on operational orientation focused on the customer.
• Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results.
• Recognizes and builds support for change and engages in constructive conflict.
• High tolerance for ambiguity in a complex environment. Makes the complex clear and easily understood by others.
• Strong relationship development, conflict resolution, and team‑building instincts, with the ability to build partnerships both internally and externally.
• Fluent in English.
• Preferred Skills
• Compliance Management
• Continuous Improvement
• Corrective and Preventive Action (CAPA)
• Developing Others
• Fact‑Based Decision Making
• Inclusive Leadership
• Leadership
• Performance Measurement
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Processes
• Quality Standards
• Standard Operating Procedure (SOP)
• Strategic Thinking
• Succession Planning

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.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs.

#J-18808-Ljbffr