Director, Commercial Quality Americas

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 were 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

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.

You will be responsible for:

• 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.
• Masters 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%.

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 () or contact AskGS to be directed to your accommodation resource.

Required Skills:

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

The anticipated base pay range for this position is :

$150000.00 - $258750.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys 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: - Experience:

Director