J&J Family of Companies [Medical] Director Quality in Japan

SUMMARY:

Lead the Ethicon / CSS Quality Operations organization in China and Japan by:

•Directing quality and compliance activities at the 2 ETHICON/CSS manufacturing locations in China and Japan

•Working cooperatively with Johnson & Johnson leaders to implement programs to improve overall quality, improve operational efficiency, enhance organizational capability and diversity, and assure regulatory compliance

•Leading actions to reduce risk of non-conforming product, ensuring the suitability and effectiveness of the manufacturing location’s quality management system

•Implementing systems and controls to ensure high-quality reliable product supply, operational efficiency and reliability

•Selecting, developing, and leading staff to perform quality functions consistent with strategic plans for ongoing implementation and improvement of the Quality System and Supply Chain processes

ESSENTIAL FUNCTIONS:

1.Champions the creation and maintenance of Credo-based environment in his/her area of responsibility, living Credo values, building trust and caring for people

2.Leads the Quality Operations staff in the development and deployment of key business, SC and Quality strategies, continuous improvements and customer focus activities

3.Develops and disseminate strategy for talent attraction, development and retention to enhance the Quality Operation talent pipeline

4.Ensuring the plant has appropriate resources with the right competencies to execute the Quality System

5.Champions cross sites, regions and franchises assignments to foster Global QA Leadership development

6.Provides active link and partnership between the manufacturing sites and Marketing Companies. Partners across the J&J enterprise in the Region through the Quality& Compliance Councils to influence the external environment and Local Regulatory bodies including State FDA bodies, PMDA

7.Participates in an active collaboration with the other regional leaders in developing cohesive, strategic and tactical responses for the business needs and QA initiatives.

8.Directs the department engaged in the development of New Product Development and Design changes to existing Products/Processes/Packages throughout the product lifecycle

9.Foster resource leverage across plants and region, ensure alignment or harmonization where required and/or appropriate

10.Executes responses to field actions and coordinates global response with the other regional directors and corporate functions.

11.Ensures the manufacturing sites assess QS effectively through internal audit and Management review and implement corrective/ preventive, improvement actions as appropriate

12.Ensures manufacturing sites implementation of Quality Systems and goals are integrated in a cost effective and productive manner also in collaboration with franchise and enterprise teams

13.Establishes and monitors metrics for the measurement of Quality indicators and Quality Costs to ensure effectiveness and value to the business

14.Leads the Quality Operations staff in the understanding, development and deployment of PE methodology, continuous improvement and customer focus.

15.Supports manufacturing sites in the investigation, evaluation and implementation of actions to eliminate root causes of non-conformances

16.Provides disposition for non-compliant products and assures escalation of potential quality or compliance problems to franchise and enterprise.

17.Provides support to multiple Medical Device Franchises in the region, to enable businesses to meet local customer and regulatory requirements

18.Ensures effective risk management processes are implemented to prevent unanticipated failure modes and ensure capability

19.Liaise with the Region and source company manufacturing sites to improve the customer experience through proactive management of complaints. Ensures the manufacturing sites address all customer feedbacks and complaint in appropriate and timely manner.

20.Enables NPI localizations/customizations of solutions to deliver market appropriate product offerings, while ensuring adherence to Enterprise and Franchise Design control processes

21.This individual has the necessary independence, authority and responsibility to initiate action to prevent nonconformities, enact remediation plans, identify and document quality problems, initiate, recommend, provide and verify solutions to quality problems and direct or control further processing and delivery of nonconforming product.

SUPERVISORY RESPONSIBILITIES:

•Direct subordinates are site Quality Operations Managers

•Reviews and participates in personnel development programs necessary to provide employee movement through prescribed promotional patterns

•Evaluates and recommends staffing requirements to insure maximum utilization of personnel to fulfill department objectives

•Approves salary increases recommendations and recommends salary increases and promotions for direct subordinates, interviews applicants for job openings, conduct performance reviews and provides guidance to subordinates

•Defines and ensures implementation of multiple new product development plans and programs

•Works effectively with marketing counterparts to prepare product pipeline strategies and to direct project execution

Qualifications

EDUCATION and/or EXPERIENCE

•At a minimum, a BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science

•A minimum of 12 years related experience and/or training; or an equivalent combination of education and experience

•Five(5) years of active management experience including direct supervision and matrix management

•Managed a plant-based organization (Quality or Operations) with multiple challenges; preferably in multiple companies and/or locations

•Experience in front-room role with FDA (or similar) inspection and Notified Body inspection

•Successfully managed a multinational department and or significant QA project

•Identified need for and directed development and implementation of at least one major process or system improvement at site or regional level

•Developed (not hired) ready now successor for leadership position (Mgr.-level)

CERTIFICATES, LICENSES, REGISTRATIONS:

•ASQ - Certified Quality Manager preferred, but not required.

•ISO 9001 - Lead Assessor Certification preferred, but not required.

•Black Belt/ Green Belt certification from a recognized program or PE leadership training from J&J within first year of hire.

LANGUAGE SKILLS

•Fluency in English mandatory – both verbal and written

•Japanese and or Standard Chinese preferred

OTHER SKILLS AND ABILITIES

•Universal Leadership Competencies

1.Integrity & Credo-Based Actions

2.Collaboration & Teaming

3.Results & Performance Driven

4.Self-awareness & Adaptability

5.Organization & Talent Development

•Differentiating Competencies

1.Sense of Urgency

2.Big Picture Orientation

•Specific Technical Skills Required

1.Process Excellence

2.Project Management

3.Risk Management

4.QSR/ISO 13485

5.Cost Accounting Principles

6.Quality Auditing

7.Operations Processes

8.Systems Development & Integration

9.Business Acumen

Primary Location

Japan-Tokyo-To-

Organization

Johnson & Johnson K.K. (8235)

Job Function

Quality (Generalist)