Director, Commercial Quality - Americas

6942-ABIOMED Inc. Legal Entity; Danvers (MA); On-site; USD 150,000 - 259,000; Full time

Benefits offered by this job

Vacation 120 hours/year

Sick time 40 hours/year

Holiday pay 13 days/year

Work/PF time 40 hours/year

Parental Leave

Bereavement Leave

Volunteer Leave 32 hours/year

401(k) plan

Pension plan

Job summary

Johnson & Johnson in Danvers, MA, seeks a Director of Commercial Quality for the Americas to lead compliance and distributor quality programs. The role oversees field actions, supplier quality, and regulatory engagement with agencies like FDA and Health Canada, ensuring customer-centric quality across commercial operations.

This leadership position requires extensive cross-functional collaboration, a strong regulatory background, and hands-on execution of CAPA, SOPs, and Change Controls to

Qualifications

• Bachelor’s level education in science, engineering, or related field.
• Master’s degree in business, science, or engineering preferred.
• Experience with global regulatory requirements and multi-site operations.

Responsibilities

• Lead Commercial Quality across Americas for compliance and field actions.
• Partner with Abiomed Americas teams to define quality plans and customer priorities.
• Oversee distributor quality lifecycle, audits, and quality agreements.
• Manage field action execution and communications, including US FDA interactions.
• Ensure SOP approvals, Change Control, and CAPA/Non-Conformance processes.
• Drive supplier quality management for marketing, promotions, and logistics.
• Collaborate with Quality & Compliance and Commercial orgs to improve efficiency.
• Provide training planning and oversight for compliant operations.

Skills

Compliance Management

Continuous Improvement

CAPA

Developing Others

Decision Making

Inclusive Leadership

Leadership

ISO 9001

Quality Management Systems

SOPs

Quality Standards

Education

Undergraduate degree in science/engineering

Master’s degree in business/science/engineering

Job description

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

We are searching for the best talent for a Director, Commercial Quality - Americas to be based in Danvers, MA. 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. Learn more at https://www.jnj.com/medtech.

Purpose

The individual will lead the Commercial Quality function focused on compliance for Americas commercial operations, field action execution, Commercial and 3PL logistics supplier quality, and supplier quality management for distributors. The incumbent will recommend and drive implementation of compliant, fit for purpose controls on these activities, with an unwavering focus on customer experience.

Responsibilities

• Partners with the Abiomed Americas Commercial and Customer Service organizations to define customer priorities and quality plans to achieve customer requirements, and support growth and market expansion.
• Implements aligned processes and procedures at Abiomed to ensure compliant, efficient, and effective Commercial Quality operations supporting the growth forecast for the Abiomed business.
• Supports the Americas Commercial organizations and leadership teams as the key Quality partner to resolve quality related issues and guide business decision making through a quality lens.
• Responsible for all Quality lifecycle aspects of the distributor network in the Americas including qualification, audit, Quality Agreement and disengagement.
• Supports distributor compliance through negotiation, relationship management and enforcement of regulations and quality agreement requirements.
• Owns the field action process execution oversight responsibility for the Americas region including correction implementation reporting.
• Responsible for customer/distributor field action communications outside of the United States.
• Interacts directly with government health authorities and notified bodies in support of audit and field action execution, inclusive of US FDA, Health Canada, ANVISA, COFEPRIS and others.
• Support Quality responsibilities including SOP approval, Change Control and CAPA/Non-Conformance management for Customer Service, Commercial Operations, Clinical Sales Training, Medical Affairs, Marketing and Platform Operations and others as required.
• Responsible for the Commercial Supplier Quality management program within the Americas region, inclusive of suppliers for marketing and promotional materials, transportation, and field action support.
• Connects the Abiomed organization to the broader J&J Quality and Compliance organizations to identify efficiency opportunities, SME knowledge, standard methodologies, and cost improvement opportunities.
• Ensures appropriate personnel training is planned and achieved to support compliant operations within commercial quality.
• Other activities as required by management.

Qualifications / Requirements

Undergraduate degree in science, engineering, or a related scientific field. Master’s degree in business, science, engineering, or a related scientific field preferred.

This role requires a diverse business background, with specific quality, regulatory and regulatory compliance competencies in the areas of commercial quality, supplier quality, distribution and customer service. Experience in positions of growing responsibility supporting large, multi-site, global organizations, with broadly based quality management experience. Experience with the global demands of the role specifically: multi-cultural / multi-country locations and healthcare regulatory requirements. Previous experience working with global regulatory agencies, e.g., US FDA, Health Canada, COFEPRIS, ANVISA supporting higher risk product classifications. Builds consensus and impacts outcome without always having line authority and can achieve trade off decisions across the organization. Must have strong collaboration and influence leadership skills to partner optimally across functions and operating units preferred. Strong analytical and strategic skills with a bifocal approach - ability to zoom-in/zoom-out for strategic and tactical, high-level, and detailed preferred. 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 and Commercial organizations. “Hands‑on” orientation focused on the customer. Accountability, with a desire to commit, and be rewarded for delivering results. Recognizes and builds support for change. 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. Fluent in English. Additional LATAM language capability is a plus. Regional and Global travel up to 20%.

Required Skills

Compliance Management, Continuous Improvement, Corrective and Preventive Action (CAPA), Developing Others, Fact-Based Decision Making, Give Feedback, Inclusive Leadership, ISO 9001, Leadership, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Processes, Quality Standards, Standard Operating Procedure (SOP), Succession Planning

Preferred Skills

Compliance Management, Continuous Improvement, Corrective and Preventive Action (CAPA), Developing Others, Fact-Based Decision Making, Give Feedback, Inclusive Leadership, ISO 9001, Leadership, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Processes, Quality Standards, Standard Operating Procedure (SOP), Succession Planning

Salary & Benefits

The anticipated base pay range for this position is : $150,000.00 - $258,750.00

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.

• 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

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

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 https://www.jnj.com/.