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:JOB SUMMARYThe Labeling Standards Lead is responsible for successful management of labeling standards and regulations.
DUTIES & RESPONSIBILITIESIn 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
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
