Commercial Quality Specialist

Johnson & Johnson•Cherry Hill, NJ

15d•$94,000 - $151,800•Onsite

About The Position

Johnson & Johnson is currently seeking a Commercial Quality Specialist , located in Danvers, MA or Peabody, MA to join our Abiomed Team. This role is currently located in Danvers, MA, but will relocate to Peabody, MA in 2027. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Due to significant growth, Abiomed is working to develop and enhance Commercial and Distribution capabilities globally, including Quality Operations support to these functions. The incumbent will be responsible for supporting multiple workstreams in support of this development activity, focused on implementation of J&J standards compliance for commercial operations, escalation and field action, 3PL logistics supplier quality, supplier quality management for distributors, storage, transportation, pick to order operations, repack/relabel, field service, product returns and material and product controls. The incumbent will complete shop floor Quality responsibilities in the distribution center following standard operating procedures to ensure compliant, and efficient activities for the region, with an unwavering focus on customer experience.

Requirements

A minimum of 4 years of relevant working experience in a highly regulated industry with the ability to communicate (oral and written) ideas and information clearly, effectively, and frequently within the internal project team and internationally.
Independent learner and critical thinker with an eye for detail.
Diverse business background, with specific quality, regulatory and regulatory compliance competencies in the areas of commercial quality, supplier quality, storage, and distribution.
Knowledge of Quality IT Systems.
Ability to build consensus and impact outcomes without always having line authority and able to negotiate trade off decisions across the organization.
Must have strong collaboration and influence management skills to partner effectively across functions and operating units.
Decisive and organized, optimistic with a continuous improvement approach.
Excellent communication / presentation skills, able to inspire trust and build credibility within the Quality & Compliance, Distribution, and Commercial organizations.
“Hands-on” operational orientation focused on the customer.
Demonstrates accountability through a strong commitment to take ownership, accept responsibility, and earn recognition for delivering measurable results.
Recognizes and builds support for change.
High tolerance for ambiguity in a complex environment.
Transforms complex ideas into clear, easily understood explanations for 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 communication to ensure effective change management.
Fluency (oral & written) in the English language is required.
Domestic and international travel up to 10% is required.
Role is based on the Peabody, MA & Danvers, MA campuses.
Bachelor’s or equivalent university degree in Science, Engineering, or a related scientific field

Nice To Haves

Master’s degree in Business, Science, Engineering, or a related scientific field
Experience with multi-cultural / multi-country locations and healthcare regulatory requirements.
Previous experience working with global regulatory agencies, e.g., HSA, PMDA, TGA, notified bodies, etc.
Demonstrates strong analytical and strategic skills with a bifocal approach—adept at zooming in for tactical, detail-oriented analysis and zooming out for high-level strategic perspective.
Knowledge of SAP S4/HANA.

Responsibilities

Partners with the Abiomed Commercial and Distribution organizations to define customer priorities and quality plans to achieve customer requirements, support growth and ensure compliant commercial and distribution operations.
Completes commercial quality related escalations in accordance with Abiomed SOPs as directed.
Executes Field Actions in accordance with Abiomed SOPs as directed.
Performs shop floor Quality activities for all Peabody DC and Danvers related distribution, transportation, and customer service, including PTO (pick to order).
Approves, leads, or assists in investigations of non-conformances, and corrective and preventive action (CAPA) for distribution/PTO, transportation, and customer service.
Facilitates constructive interactions with suppliers to optimize logistics operations, encompassing effective communication, problem-solving, comprehensive training initiatives, and the deployment of new legislation and corporate requirements.
Reviews and approves assigned related change controls for distribution, transportation, and customer service.
Defines in collaboration with Abiomed Quality Management, processes, systems, resources, and SOPs, for the organization to align with the J&J policies, J&J standards, and applicable regulations.
Develops proposals and options and builds consensus with colleagues on the solutions.
Support implementation of the aligned processes and procedures at Abiomed to ensure compliant, efficient, and effective Commercial Quality operations in support of substantial growth forecast for the Abiomed business.
Ensures appropriate self-training is planned and achieved to support compliant operations within Commercial Quality.
Ensures technical and business self-development through robust development planning and execution.
Identifies and implements cost and efficiency opportunities in collaboration with business partners in support of the Patient First agenda.
Other activities as required by management.

Benefits

employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
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
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year