Head of Quality Management Systems & Enabling Platforms Technology Quality

Company: Johnson & Johnson
Location: Raritan
Posted on: February 25, 2021

Job Description:

Job DescriptionJohnson and Johnson is recruiting for a(n) Head of Quality Management Systems & Enabling Platforms Technology Quality. The preferred location for this role is Raritan, NJ, but we can consider alternate J&J locations globally. This position may require up to 20% travel (domestic and international).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.With $82.1 billion in 2019 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. 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 Head of Quality Management Systems & Enabling Platforms - New Health Platforms, Technology Quality & Compliance ensures compliance of medical device software (SaMD) and product hosting infrastructure, both internal and hosting platforms, across the enterprise in accordance with internal policies/procedures and external regulations.* The role is responsible to ensure full compliance and adherence to company policies and procedures by providing compliance leadership, strategic direction and day to day operational support to Health Technology projects and base business support teams* This position is also responsible for providing regulatory compliance expertise and supporting any compliance related remediation efforts* This position will support internal and external health authority regulatory inspections * The position will be responsible for managing resources responsible for the approval of validation documentation deliverables including the approval to release system implementation and/or changes for production use* Attend project team meetings and provide compliance guidance and support to project and base business support team members* This role will provide an environment which encourages the company's credo and the value of a diverse workforce* This role will lead globally diverse teams in an inclusive environment* 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 stakeholdersKey ResponsibilitiesCore Responsibilities * In conjunction with franchise quality assurance teams, provides quality oversight in support of engineering, release and post-market support activities for:* SaMD - Standalone software medical devices (i.e. mobile, wearables, web applications)* Hardware integrated solutions such as software driven surgery systems (robotics)* Digital manufacturing and 3D printing* Medical device infrastructure, including IaaS and internal hosting of product software* Actively participates in all stages of design development, V&V testing and release/support activities, ensuring quality assurance considerations and requirements are met* Manages resources who are responsible for review of product deliverables per QMS requirements* Supports post-market quality activities such as change management, product complaint handling, and Deviations/CAPAs* Facilitates and communicates key strategies and business process initiatives to various cross-functional groups to gain support * Provides partnership, insight and direction to cross-functional business leaders and stakeholders regarding policies, solutions and initiatives* Utilizes knowledge of the assigned business functions to identify business needs and develop value-added solutions* Identifies potential gaps with in-scope systems, and coordinates remediation with business and IT alignment* Ensures a high degree of inspection readiness for systems within scope of responsibility * Participates in audits, approves audit non-conformity action plans and approves closure of internal audit findings* Develops KPIs and measures and reports/communicates performance * Develops continuous improvement programs to improve overall quality of delivered solutions* Develops personnel development and training programs for medical device software support, including both quality and IT* Designs and implements a Software Medical Device and product hosting infrastructure knowledge repository* Action any NPS comments, provide resolution back to Strategic Planning & Transformation* Partners with the Supplier/procurement organization to ensure supplier management processes are implemented and measured * Partners with Business Quality organizations for defining handoffs, roles and responsibilities on SAMD * Partners with Business Quality organizations to define business risks which can be mitigated by system modifications* Partners with Systems & Infrastructure Assurance organization to transition new programs post initial deployment * Relationship with the segment Quality Organizations for ensuring Quality Agreements are documented and measured. * Partners with Strategic Planning & Transformation to ensure KM database is populated* Partners with Technology Regulatory Compliance (TRC) to ensure compliance requirements are embedded into Quality Strategies* Partners with Reliability & Operational Assurance to ensure the periodic review process embeds the review of GxP controls* Ensures Feedback from Reliability & Operational Assurance is assessed to continuously improve the Quality Strategies* Partners with Reliability & Operational Assurance to devise strategy to measure adherence to Quality strategies* Tracks and documents quantifiable business results achieved from project work and writes success stories for publication that demonstrate the business value created by TQ&CStakeholder Management* Manages global teams across geographies including FTEs and contractors within a matrixed organization* Manages project/department budgets * Establishes yearly business plans for respective area* Responsible for the development of direct reports including training and mentoring to meet current and future business needs* Provides an environment which encourages the company's credo, commitment to equal employment opportunity and the value of a diverse work forcePeople Management* Participates in external/industry peer groups which focus on best practices for quality and validation of software medical devices and product hosting infrastructure platforms* Hosts/supports benchmarking sessions with peers to gain insights on industry trends in the medical device software space* 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* Supports supplier audits as neededOther Duties* Develop and maintain an effective working partnership with senior management* Collaborate with other leaders and staff within 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 reportsQualifications* A Bachelor's degree in computer science, engineering, information systems, business administration or other related field required; advanced degree preferred; solid, relevant experience may be substituted when appropriate; additional certifications a plus* A minimum of 10 years of progressive experience in the pharmaceutical/med device/biotech industry, with direct experience in healthcare technology quality management is required* A minimum of 7 years of people management experience is required* Experience with medical device software, including standalone systems is required * Experience with integrated hardware projects such as robotics and 3D printing platforms is preferred* Experience with infrastructure qualification and quality assurance activities for both internal and hosted platforms is preferred* Experience in defining and implementing quality strategy and supporting programs, especially focused on medical device software and supporting product hosting infrastructure platforms is required* Extensive experience in IT methodologies including: Agile Development, ITIL, COBIT and GAMP 5 is required* Working knowledge of information and product cyber security is preferred * Knowledge of GxP and medical device standards and regulations is required* Certified Software Quality Engineer (CSQE), Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Project Management Professional (PMP) or similar is preferred* The preferred location for this role is Raritan, NJ, but we can consider alternate J&J locations globally. This position may require up to 20% travel (domestic and international). 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.

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