Leader TQ&C EMEA (New Consumer Health Company)

Johnson & Johnson is currently recruiting TQ&C EMEA (New Consumer Health Company). This position is located in France. 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 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. 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. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen. Thriving on diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal opportunity employer. Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day.  Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues. Johnson & Johnson announced plans to separate our Consumer Health business to create a new publicly traded company. The process of the planned separation is anticipated to be completed within 24 months, and it will be subject to legal requirements including consultation with works councils and other employee representative bodies, as required, and other customary conditions and approvals.   It is anticipated that, following the wing conclusion of the transaction, this position may be conveyed with New Consumer Health. In that case, details of any planned changes would be provided to the successful candidate by New Consumer Health at an appropriate time and would be subject to any necessary consultation processes.  Job Description: Technology Quality and Compliance (TQ&C) manages the Quality and Compliance strategy for Technology systems including applications, infrastructure, and digital health solutions. TQ&C is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with the company’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 addressing compliance gaps related to audits and inspections. The Leader TQ&C EMEA is responsible for building and executing quality into enterprise-wide systems, tools, services, and infrastructure through an end-to-end- end lifecycle (design, develop, implement, maintain, retire) This position engages with project /product teams ensuring early involvement of TQ&C in the design and development of applications and infrastructure, building quality into the work product and controls within the application/solution, leveraging automation whenever feasible The individual ensures company quality standards and regulatory requirements are met for the project/product teams the under scope of responsibility The role is responsible for planning, executing, coordinating and maintaining the validation activities for GxP projects/technology product teams within their scope including approval of SDLC validation documentation, release system implementation and/or changes for production use, providing TQ&C compliance guidance and support to support team members The individual reviews and approves SOP, WIs, and policies related to regional processes and systems within their scope and supports the incident management/CAPA and NC processes for the region supported This position will support internal audits, Health Authority regulatory inspections, and system periodic reviews ensuring a high level of inspection readiness for projects/technology products/systems under their responsibility Responsible for the management of consultants and outside service providers assigned to execution activities and provides risk-evaluation guidance to TQ&C Leads and consultants to carry out validation of computerized systems and infrastructure. Serves as the TQ&C SME for regional CSV requirements engages with Regulatory Compliance to support regulatory standards and trends monitoring evaluation activities and analyzes the impact of guidance documents applicable to the region. Qualifications Position Requirements: A Bachelor’s degree in Computer Science, Information Systems, Business Administration, or another relais ted field required; relevant experience may be substituted when appropriate; additional certifications a plus A minimum of 8-10 years of progressive industry experience, with direct experience in Computerized System Validation (CSV) in GxP environments Experience authoring or approving validation deliverables, Non-conformities, Change Requests, SOPs, Validation Plans, and Reports Knowledge of Quality Management Systems, Data Iand integrity, cGMP regulations related to CSV Experience providing CSV support in at least one of the following areas: medical device software, infrastructure qualification, hosted platforms, emerging technologies (e.g., AI, ML, RPA) or externally facing digital assets (e.g., mobile apps, Websites that include both static and dynamic processing) Preferred Requirements: Working knowledge of PMO, SDLC, Testing, GAMP 5, and ITIL frameworks Working knowledge of data analytics and insights Ability to perform work with a high degree of independence in terms of self-management of a variety of tasks Solutions-oriented Solutions oriented, striving for new ways to accomplish goals, and pragmatic advising in meeting compliance requirements Works effectively in a virtual team environment; comfortable collaborating and communicating with various cross-functional groups Primary Location France-Haute-de-Seine-Issy Les Moulineaux- Other Locations France-Haute-de-Seine-Issy Les Moulineaux Organization Ethicon S.A.S. (7840) Job Function Quality Requisition ID 2206072605W