Job Description

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale and experience to reimagine the way healthcare is delivered and help people live longer, healthier lives.

In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, vision and interventional solutions with the big ideas of others to design and deliver physician and patient-centric products and solutions.

As pioneers in medical devices, we continually focus on elevating the standard of care-working to expand patient access, improve outcomes, reduce health system costs and drive value. We create smart, people-centered healthcare to help the patients we serve recover faster and live longer and more vibrantly.

SECTION 1: JOB SUMMARY*

• Lead and deliver projects of Organizational importance
• Deploy global strategies/initiatives to ETHICON INDIA plant
• Lead and Deliver new products as per market requirement
• Lead and Deliver Artwork changes as per customer and regulatory requirement.

SECTION 2: DUTIES & RESPONSIBILITIES*

Under limited supervision, general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• NPI/LCM Specification Management:
• Lead and Drive Specification management process for two India sites
• Drive Raw Material (RM), Packaging Material (PM) and Finish Goods (FG) specifications management which includes Creation of New Spec, Change in Spec, Alignment of Spec with Franchise Spec, Phasing out of Specs for Product Family for two India Sites
• Lead and Implement best practices for Specification Management
• Liaison with Worldwide SMEs for Spec Management
• Lead, Drive and Connect directly with various Internal and External stakeholders to drive and meet business objectives
• Lead and Drive Specification Management process to next level
• Lead and Partner with various functions Manufacturing, Facility, Quality, Engineering, EHS&S, Sourcing, SQM & NPI in drive Specification Management
• Lead and Drive NPI/LCM projects to update and modify Specs and other product related design changes
• Lead and Provide project governance & execution through coordination and influencing
• Build Specification Life Cycle Management Capability at the site
• Lead Support NPI/LCM design change Project
• Align all the stakeholders on Project timelines
• Schedule and lead project meetings and send regular updates
• Highlight Risk of projects and prepare mitigation plan
• Develop a plan to align, leverage and optimize the \'MAKE-plan\' processes, roles & responsibilities and metrics, translate it into yearly objectives, and manage the deployment
• Design and implement processes that provide for a high level of internal customer satisfaction.
• Provide effective and swift response to potential Business issues
• Maintain effective communication and working relationships amongst stakeholders
• Ensure 100% safety, regulatory and quality compliance as per site specific SOPs.
• Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner
• Lead and participate in Internal and External Audits
• NPI/LCM Projects:
• Discuss with marketing and gather end customer requirement in business case.
• Get business case approved from relevant stakeholders
• Prepare project plan and form project team
• Align all the stakeholders on project timelines
• Schedule and lead project meetings and send regular updates
• Highlight risk of projects and prepare mitigation plan
• Strategic Projects:
• Prepare project case for strategic initiative and get approval from relevant stakeholders
• Lead and execute strategic initiatives with the help of project team
• Prepare stakeholder updates and communication plan
• Ensure compliance adherence with respect to company policies and regulatory requirement
• Device Master File (DMF) & Artwork Management:
• Development, deployment and maintaining procedures and protocols related to product art work management as per business requirements and ensure adherence to the same.
• Lead and/or support NPI/LCM Projects and initiatives while executing the artwork changes and document the same on time in the business systems
• Cater to tender business-relate artwork changes and requirements.
• Maintain Device Master File (DMF), Product label (artwork) and leaflet repository.
• Ensure self-training and train others on functional procedures and protocols.
• Direct and guide product label graphics and artwork agency to deliver required artwork flawlessly and on time and within cost budgets.
• General Responsibilities
• Responsible for communicating business related issues or opportunities to next management level
• 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

Johnson & Johnson