Job type: Full-time

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Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.

With $82.6 billion in 2020 sales, Johnson & Johnson is the world’s most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. There are more than 260 Johnson & Johnson operating companies employing over 135,000 people and with products touching the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

Position Summary

This position reports to the VP J&J Medical Device Q&C CQO and oversees Sr. Director and Director-level direct reports accountable for business process ownership, oversight and governance of Post Market Safety Surveillance, Customer Experience Engineering, Commercial Quality and Design Quality Engineering as well as management of the global Complaint Processing and Commercial Quality teams.

This individual will be the catalyst for orchestrating all the elements of the E2E MD Quality organization in service of the customer and patient. They will ensure through the delivery and deployment of a customer first mandate they transform the customers experience, leveraging patient insights, data analytics & emerging technologies. They will actively engage and partner with Commercial leaders across Medical Devices to define and prioritize the opportunities for customer experience enhancements that will drive better patient and business outcomes. This role is integral in establishing and driving internal partnerships across the Franchises, Commercial teams, R&D and SC/Deliver to ensure we create a more patient-centric design and offering across the MD Q&C organization. The leader of this team will have touchpoints that extend to key areas of the business (R&D, SC, Commercial) and will be relied upon to ensure the highest quality experiences for our patients and customers across MD.

Major Duties & Responsibilities

General
  • This role is responsible to establish and lead quality and compliance management and promote a process improvement culture within the business. The role ensures corrective and preventive actions are taken to mitigate potential or actual non-compliance risks and ensure compliance to attain world-class operational/customer focused capabilities and clear alignment to company strategic objectives and quality policies.
  • Assures compliance with global regulations (FDA, ISO 13485, Japanese MHLW, Brazilian ANVISA, EUMDR, etc.) as well as relevant local regulations
  • Proactively monitors global health authorities for changing regulations and implements plans to maintain compliance

Global Complaint Processing & Post Market Safety Surveillance
  • Accountable for overall strategy, oversight of all activities associated with PMSS, associated quality management systems, and regulatory compliance.
  • Ensure execution timeliness and quality of all complaint intake processes, investigations, adverse event, and Medical Device reporting in accordance with procedures, standards, and regulations.
  • Partners with Operating Franchises and end to end business partners to proactively identity potential risks, safety issues, trends, and opportunities to resolve customer issues through Franchise Fast Track program and RRT.
  • Develops digital strategy and implementation plan for PMSS processes in order to achieve an exceptional customer experience and drive to enable internal efficiencies.
  • Develops strong partnerships with outsourced providers to ensure quality and efficiency
  • Partner with Franchise leaders to ensure customer centric process optimization and execution

Commercial Quality
  • The position provides leadership, oversight, and/or support to Q&C activities in Local Operating Companies, Distribution Centers, Third Party Logistics providers, Transportation, and Customer Service functions,. Facilitates collaboration across the Q&C community within the region and champions initiatives to ensure that the regions are well represented in global / enterprise forums and that capabilities are in place to meet the strategic growth projections in the regions.
  • Develops strong partnerships with business partners to enable business growth
  • Works closely with Franchise commercial teams to enable flawless new product launches
  • Proactively gathers regional customer insights and develops improvement plans in order to drive an exceptional Customer experience

Customer Experience Engineering
  • Create innovative approach in Medical Device Q&C to establish a strong focus on the customer experience
  • Identify opportunities to improve the Customer Experience using a wide variety of VOC methods and data.
  • Using robust problem solving methodologies, identify the root cause of quality issues, develop improvements and/or corrective actions and implement said improvements through strong end to end partnering
  • Develop a standard prioritization process and business case model
  • Establish a project portfolio governance process to include project monitoring, resource model and benefits tracking
  • Broaden the quality concept beyond the normal “product” quality and evolving it to ensure a quality focus on the services and on the experience itself
  • Partner closely with the Enterprise CXE COE to ensure strategy alignment and best practices

General team management and leadership
  • Create an environment that thrives on diverse perspectives, backgrounds, and talent to generate innovative ideas or solutions, solving organizational challenges
  • Lead and hold others accountable to talent acquisition, performance, and development objectives
  • Create a high performing team environment and cohesive culture
  • Talent development and capability building
  • Credo based actions and employee engagement
  • Mentoring coaching and stakeholder management activities.

Qualifications

Required Minimum Education: Undergraduate degree in a related discipline.

Required Qualifications
  • Minimum 14 years’ experience in managing many aspects of Quality Management Systems in an international, global context, in a regulated healthcare environment.
  • Specific, significant experience across product platforms, Post Market Surveillance, and functional knowledge of / experience in Quality and Compliance as well as practical experience in Design Quality, Risk Management and Process Improvement methodologies.
  • Previous experience at a senior management level with demonstrated track record of successful results in goal setting and managing multi-million-dollar budgets is required.
  • Experience in more than one of the following preferred (cross-sector): Consumer Products, Medical Devices and Diagnostics, Pharmaceuticals

Required Knowledge, Skills And Abilities
  • Developing a high performing team with the ability to lead in a matrixed environment
  • Creating a direct and indirect organization with a culture of global customer focus and the ability to deliver
  • Ability to shape, creating a future vision and gaining support and alignment to that vision
  • Attracting and developing superior talent
  • Building interdependent partnerships, acting as the mediator between organizations while optimizing the value proposition
  • Analytical skills and experience leading risk-based oversight programs
  • Organizational change management experience
  • Project management experience
  • Executive presentation skills
  • Collaborative approach and ability to connect
  • Ability to managing complexity and ambiguity
  • Bifocal approach - ability to zoom-in/zoom-out for strategic and tactical, high-level and detailed, etc.
  • Ability to lead in the context of Our Credo.

Travel on the Job: Yes, up to 25%

Physical Location of Role: NJ - US, Zug - Switzerland or Singapore

Primary Location

United States-New Jersey-Somerville-

Other Locations

North America-United States-New Jersey, Asia Pacific-Singapore, Europe/Middle East/Africa-Switzerland-Zug

Organization

Ethicon Inc. (6045)

Job Function

Quality

Requisition ID

2105996976W

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Deadline: 04-05-2024

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