Manager, US Field Inventory Commercial Quality

Biopharma Careers; Raynham (MA); On-site; USD 102,000 - 177,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, US Field Inventory Commercial Quality to join the DePuy Synthes Quality organization in the United States. This remote role welcomes candidates from any state and references a broad US focus in Field Inventory and Quality leadership.

The role emphasizes governance of CGMP, audits, CAPA, and collaboration with Franchises, 3PLs, and internal teams. Excellent communication and leadership are required to succeed.

Qualifications

• 6-8 years of experience in a highly matrixed organization.
• Demonstrated ability to manage critical audits
• Ability to lead and influence across functions
• Excellent communication and collaboration skills

Responsibilities

• Ensure Depuy Synthes Commercial Quality compliance with ICQA and contracts.
• Oversee cGMP storage, handling, distribution, and quality investigations.
• Serve as Quality representative on project teams and drive CAPA.
• Manage or coach teams in people development and performance reviews

Skills

Leadership

Communication

Project management

Quality systems

CAPA

Education

Bachelor's degree

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

Job Function

Quality

Job Sub Function

Customer/Commercial Quality

Job Category

People Leader

Job Posting Locations

Bridgewater, Massachusetts, United States of America, Mooresville, Indiana, United States of America, Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America

Job Description

We are searching for the best talent for Manager, US Field Inventory Commercial Quality to join our DePuy Synthes Quality organization located in the United States.

This is a remote role available in all states within the 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.

About Orthopaedics

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Key Responsibilities

• Where applicable, ensure Depuy Synthes Commercial Quality compliance to the Inter-Company Quality Agreement (ICQA) or legal contracts, including but not limited to: Audit and Inspection Management, Field Actions, Management Review, Purchasing Controls, Delivery Service Incidents, Product Quarantines, Holds, Recalls, Material and Product Controls.
• Where applicable, ensure compliance to the Quality Agreement (QAA), including but not limited to, Field Inventory standard, Inspection instructions, Regulatory Compliance, Change Control, Supplier monitoring, Quality Event Management, Non-Conformance, CAPA, Storage, Handling and Distribution, Product Returns and Disposal.
• Oversight of process and systems related with cGMPs, storage handling and distribution, quality investigations and managing partnerships with Franchises, 3PL and partners. Serve as single point of contact to internal and external partners on distribution quality related matters and liaise with other quality organizations to drive timely resolution of quality related issues.
• Create, review and approve assessment plans, risk assessment reports, non-conformance reports, corrective and preventive actions, audits, and other documentation.
• Support leadership and compliance activities including, but not limited to the creation and revisions of global and local procedures. Evaluate overall compliance risk, recommend corrective actions and track progress.
• Serve as Quality representative on project teams.
• Escalate all appropriate issues according to policy and report regional metrics as required.
• Perform managerial responsibilities in accordance with the organization's policies and applicable laws, including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; addressing complaints; and, resolving problems. Responsible for the overall direction, coordination, structure, and evaluation of employees.
• Manage or collaborate with employees in the areas of people development, skill development and career development

Qualifications

• 6-8 years of relevant experience working in a highly matrixed organization is required .
• A minimum of a Bachelor’s degree is required.
• Demonstrated ability to manage critical audits
• Ability to build consensus and lead individuals through change; strong project management experience
• Excellent communication skills and strong collaboration skills; partner effectively across functions
• Ability to make the complex clear and easily understood by others
• Flexibility to work independently and on teams and has excellent time management skills to handle multiple projects and deadlines.

Johnson & Johnson announced plans to separate our Orthopaedics 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.

If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.

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.

#LI-Remote

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)
• Team Management

The anticipated base pay range for this position is

$102,000.00 - $177,100.00

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)).

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 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