Director Commercial Quality, Americas

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:

Professional

All Job Posting Locations:

Bridgewater, New Jersey, United States of America, Jacksonville, Florida, United States of America, Mooresville, Indiana, United States of America, Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America

Job Description:

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

Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

We are searching for the best talent for Director Commercial Quality, Americas.

This is a hybrid role available in all states within United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

• Bridgewater, NJ

• Raynham, MA

• Warsaw, IN

• Mooresville, IN

• Jacksonville, FL

• Palm Beach Gardens, FL

The Director Commercial Quality, Americas is responsible for overall Quality & Compliance (Q&C) leadership in North America (NA) for DePuy Synthes (DS). These responsibilities will include government/health authority interactions when required, Q&C oversight of Local Operating Companies (LOCs), commercial entities, and post market surveillance activities. This includes all distribution centers, warehouses and third party logistic operations affiliated with DePuy Synthes for NA.

Key responsibilities:

• Implement and manage the DS Quality Management System for the Commercial Quality (CQ) organization.  They will be responsible for all DS Q&C requirements in NA  including compliance to all applicable  local government regulatory agency regulations.

• Partner with Global Quality, Supply Chain (SC) and commercial organizations, including partnering with Regional leadership teams to drive continuous improvements in Q&C in their respective region.

• Select, train and develop talent to ensure needed successions and bench strength depth and availability of resources to support the QMS objectives development and maintenance.

• Makes decisions on significant quality and product issues.

• Prepares department budgets and executes against approved plan(s).

• Responsible for the management of on-site external agency audits to ensure maintenance of regulatory approvals, licenses, and standards. Lead, coordinate and prepare for external audits.

• Proactively monitors, analyses and improves all aspects of Quality Compliance, Quality Control and Quality Assurance in order to drive the Total Customer Experience.

• Responsible for escalation of relevant issues within the region to the global Q&C organization per procedures, facilitating and/or leading all aspects of compliance to the non-conformance and CAPA processes, ensuring compliance with customer complaint and reporting process(es), as well as all quality assurance components of the LOCs and distribution networks.

• Communicate and partner with other CQ professionals to implement a worldwide quality management system for DS.

• Analyze global trends or early warning signals and proactively prepare for external/governmental audits.

• The Voice of Customer (VOC) for the region for product quality and regulatory compliance.

• Create product quality and compliance Key Performance Indicator(s) specific to the region and implement improvement plans.

• Develop and implement quality procedures specific to the region as necessary.

• Collaborates with other functions across the organization and regions primarily Regulatory Affairs, Medical Affairs, Commercial Quality, Clinical, Legal, and Regional Market Managers to ensure business support and continuity ensuring continuous compliance to regulations and support of new product launches.

Qualifications/Requirements:

• University/Bachelor’s Degree or Equivalent is required. Focus degree in Science, Engineering or Technical discipline is preferred.

• A minimum of 10 years of work experience in a Quality Role within Medical Device, Pharmaceutical, Consumer Good, Food or other GMP controlled environment.

• Thorough understanding of regulatory / compliance requirements for North America (US and Canada) region.

• Experience in Post Market Safety Surveillance and LOCs activities.

• Front room regulatory body audit experience.

• Experience in Distribution Center management.

• Strong communication, interpersonal and organizational skills.

• Experienced with direct communications and interactions with end customer/ user.

• This position may require up to a 25% of domestic and/or international travel.

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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

 

 

Preferred Skills:

Business Alignment, Compliance Management, Consulting, Continuous Improvement, Fact-Based Decision Making, ISO 9001, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Stakeholder Engagement, Standard Operating Procedure (SOP), Tactical Planning, Technical Credibility

 

 

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.

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: - https://www.careers.jnj.com/employee-benefits