Job Function: Quality
Job Sub Function: Customer/Commercial Quality
Job Category:Professional
All Job Posting Locations:Raynham, Massachusetts, United States of America, Remote (US)
Job Description:We are searching for the best talent for Manager, Commercial Quality Global Labeling and IFU (Instructions for Use) to join our DePuy Synthes Quality & Compliance 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 OrthopaedicsFueled 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
The Manager, Commercial Quality Global Labeling and IFU will lead end-to-end improvements of global labeling processes, spanning business-unit labeling practices, country-specific label design, application, and execution, to ensure compliance and operational excellence across Distribution Centers and third-party logistics partners. This role will influence and guide a team supporting regional supply chain labeling systems and Instructions for Use (IFUs), maintain audit readiness, and ensure compliance with emerging regulations for labeling customizations to protect the right to sell across all medical device businesses at the country level. This role will act as the strategic interface between Supply Chain, Deliver Functions, Regulatory Affairs, and Commercial Quality, providing day-to-day operational support and driving changes related to new product introductions, product transfers, and regional regulatory updates.
Key Responsibilities
- Leads establishment of end-to-end processes and systems for Global Labeling, in partnership with Regulatory Affairs, Supply Chain, Q&C and Deliver functions, to ensure compliance of Medical Device products commercialized / distributed globally.
- Supports the sustainability of Right Stage Customization system & processes.
- Supports the sustainability of the Repack Relabel (RPRL) Power App.
- Supports the implementation and sustainability of the new global process for DePuy Synthes electronic IFU deployment.
- Serves a key point of contact and voice of Commercial Quality (DCs, LOCs) on the Right Stage Customization governance.
- Supports Deliver sites with troubleshooting and problem solving, facilitating investigations and connections with key stakeholders from the E2E process
- Monitors processes improvement and evolutions through NC, CAPA and Escalations trends, continuously improving the process based on trends & root causes identified.
- Develops, leverages, and implements forward thinking innovation strategies and capabilities related to this process, (such Advanced Analytics, Artificial Intelligence, digital product, and supply chain solution support) connected with the overall Digital QMS and E2E Integrated Data strategies.
- Maintains close connection with the regions to share improvements and trends related to this process, collect additional insights from key business partners and from customers, ensure new or emerging regulations are considered as part of processes enhancements and maintain global standardization approach.
- Executes activities under GxP and ensure ongoing audit readiness.
Qualifications
Education
- Bachelor's degree required (Engineering, Life Sciences, Regulatory Affairs, or related field).
- Advanced degree (Master's, MBA, or equivalent) preferred.
Experience and Skills
Required:
- 6+ years of experience in Quality, Regulatory Affairs, or Compliance within a medical device and/or regulated healthcare environment.
- Labeling and/or experience in last mile operations
- Strong planning, project management, risk management and change management expertise.
- Strong working knowledge of global medical device including labeling regulations and standards (e.g., FDA, EU MDR, ISO 13485).
- Process Excellence (Lean, six sigma) experience across diversified business areas or equivalent quality standards programs.
- Successfully executes work in a highly matrixed, cross functional, often ambiguous environment
- Experience with Microsoft Power Apps
- Demonstrated track record of process improvements, turnaround, and transformations.
- Excellent decision-making and problem-solving skills
- Team building, influencing, and development capabilities
Preferred:
- Extensive experience in US Health Authority audits.
- Experience operating in a global, matrixed Orthopedics organization
- Track record of driving large-scale process improvement and transformation initiatives.
- Familiarity with digital quality systems and data-driven compliance monitoring.
- Excellent written and verbal communication skills, including interaction with regulatory authorities.
Other
- Travel: Limited; Up to 25%, domestic and international.
- Certifications: ASQ, PMP, or similar certifications preferred but not required.
- Language: English required; additional languages a plus.
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.
#LI-Remote
Required Skills:Preferred Skills:Coaching, Compliance Management, Consulting, Continuous Improvement, Fact-Based Decision Making, ISO 9001, Performance Measurement, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Stakeholder Engagement, Standard Operating Procedure (SOP), Technical Credibility
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 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
