Senior Director, Commercial Quality Abiomed (USA)

6942-ABIOMED Legal Entity • Cherry Hill, NJ

38d • Onsite

About The Position

This role is responsible for leading multiple workstreams to develop and enhance Commercial and Distribution capabilities globally, including Quality Operations support and integration with the J&J Deliver organization. The focus is on implementing J&J standards compliance for commercial operations, 3PL logistics supplier quality, storage, distribution, transportation, kitting operations, product returns, and material and product controls. The incumbent will recommend and drive implementation of compliant, fit-for-purpose controls globally, with a focus on customer experience. This role also manages the quality aspects of an approved capital project involving the relocation of Abiomed operations from Danvers, MA to Peabody, MA, including material receiving, inspection, field service, handling, storage, distribution, product returns, and kitting operations. The incumbent will represent Quality on the Project Leadership team and is the Directly Responsible Individual for Quality for this project.

Requirements

• Undergraduate degree in science, engineering, or a related scientific discipline.
• 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.
• Builds consensus and impacts outcome 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, etc, and a history of success and credibility resolving complex regulatory compliance issues.
• Decisive, organized, and able to lead people within a complex global environment.
• Excellent communication/presentation skills, able to inspire trust and quickly build credibility within the Quality & Compliance, Supply Chain, and Commercial organizations.
• "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.
• 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.
• Engages in open and honest communications to ensure effective change management.
• Fluent in English

Nice To Haves

• Master's degree in business, science, engineering, or a related scientific discipline.

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.
• 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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Director