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Director, Process Management- Production Standards
Bridgewater, New Jersey; United States
Requisition ID: 00001CBO
Johnson & Johnson is recruiting for a Director, Process Management- Production Standards and can be located anywhere in the Globe, including remotely.
Johnson & Johnson Family of Companies, caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
With $74.3 billion in 2014 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 and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 119,000 people in 60 countries throughout the world.
You, the Director, Process Management will:
The Director, Process Management reports to the Senior Director, Global Standards & Processes (GQS). This role will provide ownership and leadership of assigned standards and processes across the Enterprise. This role will establish and lead center of excellence, that will provide process ownership and subject matter expertise and that will maintain, sustain and continuously improve standards and processes across the Enterprise and monitor the performance of those standards and processes through metrics and analytics.
This role will assure the highest levels of internal customer satisfaction around the world, responding to internal customer feedback, supporting internal customer needs and help to ensure the quality of our products and excellent regulatory compliance performance.
The Director, Process Management will work closely with internal and external stakeholders, for example JJRC, Segment Subject Matter Experts, Segment Quality leads, etc. to drive the efficient, effective support and maintenance of standards.
- Actively develop and manage business partner relationships with subject matter experts and external organizations to assure consistent processes, and to provide guidance / direction regarding execution of those processes.
- Provide support to segments for effective implementation of standards.
- Provide audit and inspection support to business partners as required
- Serve as business sponsor for enterprise tools developed and deployed by SC associated with the assigned standards.
Provide updates to Standards and Processes councils and other levels of management as needed
- Stewardship of assigned standards, continuously improve and maintain standards in compliance with regulations and consistent with industry trends
- Own processes associated with standards for assigned standards
- Work in collaboration with JJRC to drive appropriate interpretation of standards, and proactively monitor internal and external audit observations and industry trends
- Monitors through metrics the performance of the assigned standards and processes
- Work in collaboration with the Training Teams to develop and deliver effective training on assigned standards
- Management and talent development of staff
- Establish external relationships to interpret and influence emerging trends in regulations and requirements on a global basis
- Bachelors’ degree is required, studies in science, engineering or equivalent experience is preferred
- Minimum of 10-15 years of business experience in a regulated environment.
- 8+ years in managing many aspects of Quality Management Systems in an international, global context, in a regulated healthcare environment is required.
- Specific, significant experience in Quality Systems processes, and functional knowledge of / experience in Quality and Compliance is required.
- Previous experience at a senior management level with demonstrated track record of successful results.
- Experience in more than one of the following preferred (cross-sector): Consumer Products, Medical Devices and Diagnostics, Biotech, or Pharmaceuticals.
- Must have Subject Matter Expertise in the following Quality Standards: Production Process Controls and Final Release; Handling, Storage, and Distribution; and Material and Product Controls
- Must have working knowledge of the following Quality Standards: Laboratory controls and stability, Purchasing Controls, Labeling and Packaging, Facilities, Utilities and Equipment,
- Identification and Traceability, Validation, and Product Discontinuation
- Developing a high performing team with the ability to lead, even 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
- High degree of customer focus, initiative, innovation, and team work.
- Building interdependent partnerships, acting as the mediator between organizations while optimizing the value proposition
- Ability to build and nurture strong, positive relationships with cross-functional teams.
- Ability to manage multiple tasks, prioritize with minimal direction and escalate to management when appropriate.
- Analytical skills and experience leading risk-based oversight programs
- Project management experience
- Ability to managing complexity and ambiguity
- Ability to lead in the context of Our Credo.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Bridgewater
North America-United States, Asia Pacific, Latin America, North America, Europe/Middle East/Africa
Johnson & Johnson Services Inc. (6090)