Labeling Standards Lead

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:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Cincinnati, Ohio, United States of America

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 https://www.jnj.com/

JOB SUMMARY

The Labeling Standards Lead is responsible for successful management of labeling standards and regulations.

DUTIES & RESPONSIBILITIES

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Lead identification and understanding of labeling requirements from standards organizations or regulatory bodies.  
• Drive consistent interpretation of labeling requirements through cross-functional, cross-franchise, collaboration to meet business needs.
• Maintenance, and continuous improvement of applicable labeling procedures.
• Participates in review of emerging new labeling guidance and guidance changes; ensures consistent implementation via procedure changes, as needed.
• Accountable for leading labeling-owned gap assessments and serve as subject matter expert for non-labeling owned assessments.
• Support internal and external audits; notified body responses and findings related to ISO and Regulations.
• Develop methods to elevate knowledge of ISO/Regulation requirements to achieve a compliant label.
• Provide ownership to CAPAs (Corrective And Preventive Action), Audit Findings and Non-conformances as assigned
• Manage or lead labeling-related improvement projects of moderate size, complexity, and business impact. 
• Problem analysis and resolution.
• Responsible for communicating business related issues or opportunities to next management level
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Qualifications:

 Education:

• Minimum of a Bachelor’s or equivalent University Degree required

Required:

• Minimum 4 years relevant work experience

• Experience in the Medical Device industry or medical field
• Verbal and written communication skills
• Project Management experience, with FPX and/or PM Mastery certification
• Working in a matrix environment across geographies and organizations
• Strong analytical and problem-solving skills
• Works effectively and builds relationships across functions and stakeholders
• Strong Organizational and Prioritization skills
• Negotiation and Conflict Resolution Skills
• Knowledge of QMS and Medical Device Regulations
• Personal computer skills, MS Office applications, Word, Excel, PowerPoint, Visio, Teams

Preferred:

• Process Excellence Green Belt required, Black Belt in 6-Sigma or Lean
• Change Management experience
• Understanding Regulations and Standards for labeling
• Working knowledge of ERP and PLM systems
• Process Development and improvement
• Demonstrated understanding of an end-to-end Supply Chain
• Ethicon product knowledge

Other:

• May require up to 30% domestic and/or international travel to other locations and sites

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

Required Skills:

 

 

Preferred Skills:

Agile Decision Making, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Emerging Technologies, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Product Costing, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy, Validation Testing, Vendor Selection

 

 

The anticipated base pay range for this position is :

$94,000.00 - $151,800.00

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