Johnson & Johnson is recruiting for a Lead, Technology Quality and Compliance – Data & Analytics in the Technology Quality & Compliance (TQ&C) organization ideally located in Piscataway, NJ with consideration given to any global Johnson & Johnson location.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.
With $81.6 billion in 2018 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. There are more than 250 Johnson & Johnson operating companies employing over 130,000 people and with products touching 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.
The Lead, Technology Quality and Compliance - Data and Analytics ensures compliance of data platforms such as MDM, Data grids, data lakes, data warehouses and analytics platforms (i.e. advanced analytics, artificial intelligence/machine learning) in accordance with J&J SDLC, assures compliance within the enterprise with applicable global regulations, advise on quality matters, and assist with closing compliance gaps related to audits and inspections. Responsibilities include:
Provide end to end quality oversight including all pre-production (i.e. Plan, Design, Validation and Release) and post-production (i.e. availability management, problem management, change control, etc.) for the following DnA solutions:
- Master data management (MDM) for supply chain, commercial (i.e. vendor/patient), clinical development etc.
- Data hosting platforms including Johnson and Johnson’s enterprise data grid (EDG), data lakes and warehouses
- Tools that support the data lifecycle including data ingestion, data processing, data storage, data access and data reporting
- Analytics platforms including business intelligence, data mining, artificial intelligence/machine learning
- Integration with IoT devices including mobile, sensors, wearables, etc.
- Perform pre and post review and approval of validation test scripts including test defects
- Author, review, and/or approve validation documentation deliverables such as but not limited to Compliance Plans, User Requirements, System Tests, User Acceptance Tests, Traceability Matrix, and the Compliance Report including final release and approval for production use
- Perform review and approval of system change controls including final release approval for production use
- Ensure a high degree of Inspection Readiness for Systems in GQ-IT portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within scope of responsibility
- Participate in audits, approves audit non-conformity action plans and approve closure of internal audit findings
- Facilitate education and training to the organization on GQ-IT program procedures and controls
- Lead and mentor a team of internal and external resources through the system lifecycle and utilizes expert knowledge regarding risk management practices.
- Assist or drive status meetings to communicate and address project risks or issues
- Works collaboratively with project teams to keep them informed of project status, including any barriers
- Builds and maintains trusting, collaborative relationships and partnerships with internal and external partners which help accomplish key business objectives, and helps others to do the same
- Defines internal standards to move the organization toward a more positive risk management posture by utilizing extensive knowledge of current and emerging best practices in risk management
- Proactively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry standards
- A Bachelor’s degree in Computer Science, Information Systems, Business Administration or other related field required; additional certifications a plus
- A minimum of five (5) years of progressive experience in the pharmaceutical/med device/biotech industry, with direct experience in Computerized System Validation activities is required
- Experience in authoring or reviewing validation protocols, Non-conformities, Change Requests, SOPs, Validation Plans and Reports is required
- Strong QA analyst skills with experience in Computerized System validation in GxP environments in the pharmaceutical industry preferred
- Must have the ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands
- Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is preferred
- Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820 is required
- Working knowledge of Global regulations like Annex 11, ISO preferred
- Experience in Testing Management Tools like HPALM is required
- Superior written and oral communication and excellent Microsoft Office skills required
- Knowledge of SDLC Quality Management process and Computerized System Validation principles is required
- Strong skills in interdependent partnering and influencing required
- Must have the ability to perform work with a high degree of independence in terms of self-management of a large variety of tasks and initiatives regarding Quality
- Ability to travel up to 10% of the time domestically and/or globally may be required
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.
United States-New Jersey-Piscataway-
North America, Europe/Middle East/Africa, Asia Pacific, Latin America
Johnson & Johnson Services Inc. (6090)