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 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. Scope to be inclusive of, but not limited to facility cleaning and maintenance, pest control, calibration, temperature control and monitoring, kitting/packaging operations, labeling control, material control, returned product control, recalled product control, shipping, distribution, indirect material supplier purchasing controls and internal audit. 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. Special 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. A key feature of this role is the high degree of change management that will occur through the assignment. 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, 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. Required Skills: Builds consensus and impacts outcome without always having line authority and can negotiate trade off decisions across the organization. Must have 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. Education Required: Undergraduate degree in science, engineering, or a related scientific discipline. Preferred: Master's degree in business, science, engineering, or a related scientific discipline. Core Competencies Required: 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 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 and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (View email address on click.appcast.io) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $178,000.00 - $307,050.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - 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 Do Not Sell or Share My Personal Information Limit the Use of My Personal Information