Johnson and Johnson is recruiting for a Leader Quality Management Systems – Document Management and Training, Technology Quality and Compliance. The preferred location for this role is Raritan, NJ. Will consider alternate J&J locations globally as well as remote location.
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 innovative ideas, products and services to advance the health and well-being of people.
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. 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.
Technology Quality and Compliance (TQ&C) manages the Quality and Compliance strategy for IT systems, including applications, infrastructure, and digital health solutions for J&J. TQ&C is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with J&J’s Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with closing compliance gaps related to audits and inspections.
The Leader of Quality Management Systems – Document Management and Training, Technology Quality and Compliance (Senior Manager) is responsible for the day-to-day operations of the Document and Training team. This position defines and executes the strategy and roadmap for Document Management and Training, including process definition and technology platform requirements.
The position will be responsible for innovating and streamline the JJT-TS and TQ&C Document Management and training processes.
- This role will be responsible for defining, implementing, and managing the Global Document and Training management process for all controlled documents and quality training for IT
- This role will own and manage the technology training program while ensuring compliance with quality system processes
- This role will play a key role in driving the technical vision for document and training management system and integration with other quality elements in the technology QMS
- This role will lead globally diverse teams in an inclusive environment
- This role will provide an environment that encourages the company’s credo and the value of a diverse workforce
- This role serves as a trusted partner across the Technology Quality & Compliance organization, requiring strong collaboration skills at the senior leadership level, and includes making recommendations for improvements relevant to senior-level stakeholders
Establish Document and Training management strategy for JJT-TS and Technology Quality:
- Defines and executes the Strategy and roadmap for Document Management and Training, including process definition and technology platform requirements
- Defines 3-to-5 yr. strategic roadmap for document and training management process adherence
- Business Process Owner for Document Management and Training Management
- Takes action on any NPS comments and provides resolution back to SP&T
- Partners with SP&T to ensure KM database is populated
- Partners with TRC to ensure compliance requirements are embedded into Quality Strategies
- Partners with R&OA to ensure the periodic review process embeds the review of GxP controls
- Tracks and documents quantifiable business results achieved from project work and writes success stories for publication that demonstrate the business value created by TQ&C
- Monitors for emerging industry trends, technology and regulations
- Responsible for department budget for system maintenance and upgrades
- Ensures senior Quality and JJT leadership receives periodic updates on effectiveness and suitability of Document and Training Management processes and activities
- Responsible for negotiating with internal partners and external suppliers to establish favorable support rates
Define Process and Technical Vision for Document and Training Management:
- Partners with key technology partner to provide user and functional requirements to enhance document and training management system tools
- Develops and support continuous process / system improvement activities
- Utilizes PE / Lean tools to streamline document control
- Responsible for delivery and financials of any new initiatives related to document and training management process improvements, document management/training management integrations with other tools, or process improvement for other quality elements using associated electronic systems
- Ensure timely reports of status, metrics and time sheets as required by the Technology Quality and Compliance organization
Document and Training Management Quality Element Leader:
- Manages team for Document and Training Management processes providing guidance and consultancy to business partners as needed
- Responsible for the execution of document and training management SLA’s and relevant metric targets
- Responsible for the development, reviews and approval of SOPs, WI’s and policies related to Document and Training Management to ensure proper control of quality elements
- Develops training content for Document and Training Management tool and processes
- Acts as SME representing Document and Training Management during internal audits and external regulatory inspections
- Communicates effectively as a spokesperson for document and training management
- Leads effectively through times of crisis and ambiguity
Staff Development:
- Responsible for the development of direct reports including training and mentoring to meet current and future business needs.
- Works with TQ&C leadership and pillar leaders to nurture future leaders and create opportunities to grow
- Mentors talent and helps them grow in their careers
- Provides an environment which encourages the company’s credo, commitment to equal employment opportunity and the value of a diverse work force
- Develop and maintain an effective working partnership with senior management
- Collaborate with other leaders and staff within the Technology Quality and Compliance group to ensure each function is executed in an efficient manner
- Ensure adherence to the TQ&C Operating Model
- Ensure timely reports of status, metrics and time sheets as required by the Technology Quality and Compliance organization
- Ensure timely completion of assigned training and expense reports
- Performs other work-related duties as assigned
Qualifications
- A Bachelor’s degree in Computer Science, Engineering, Information Systems, Business Administration, or other related field required; Advanced degree preferred
- A minimum of 8 years of progressive experience required
- Experience in pharmaceutical/med device/biotech industry, with direct experience in Healthcare Technology prefered
- Experience managing Document Management and/or Training Management systems/processes is required
- Extensive knowledge of GxP health authority regulations as it pertains to technology required
- People management experience is preferred
- Experience supporting internal and external Compliance audits with FDA, Notified Bodies and international regulatory authorities is preferred
- Demonstrated experience in writing and managing compliance documentation including the ability to coach others for the quality of content required
- Demonstrated ability to manage complex projects, priorities and multiple tasks is required
- Understanding of major hardware and software platforms preferred
- Process Excellence certifications are preferred
- Strong influencing and communication skills, both verbal and written and both at business and technical levels
- Works effectively in a virtual team environment required
- This position may require up to 10% travel (domestic and international)
Work location is flexible if approved by the Company except that position may not be performed remotely from Colorado.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location
United States-New Jersey-Raritan-1003 US HIghway 202
Other Locations
North America, Asia Pacific, Latin America, North America-United States, Europe/Middle East/Africa
Organization
Johnson & Johnson Services Inc. (6090)
Job Function
Quality
Requisition ID
2105911321W
Source: Indeed.com
Click Here To Apply
