AddressDescription
Johnson & Johnson is recruiting for a Manager, Infrastructure in Raritan, NJ or near a Johnson & Johnson office in India, Switzerland, Belgium, or the United States. This position may require up to 20% travel (domestic and internationally).
Per our J&J Flex Policy, the expectation for this position is to work in the nearest Johnson and Johnson office 3-4 days per week and work from home 1-2 days per week.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Enterprise Quality is a comprehensive organization within J&J that focuses on ensuring the highest standards of quality & compliance. It encompasses a Quality Operations division that handles Computer System Validation (CSV), QMS Management, and Commercial Quality Shared Services, including specialized support for Transportation Operations and Temperature Control. Additionally, it includes a Transformation Office dedicated to steering strategic imperatives and enhancing the Quality & Compliance organization's strategy through initiatives like Data Strategy, Automated Product Release, and Digitalization of Quality Management Systems. The group further comprises a Data & Digital Strategy function tasked with developing and executing a holistic digital and data strategy to improve quality and compliance, covering areas such as Data Foundations, AI/ML & IoT technologies, Quality & Compliance Innovation, and Digital Assets validation. To facilitate the deployment of these strategic initiatives, the group employs two Deployment Offices for the MedTech and MedTech segments and maintains a global presence through three regional leaders managing operations in Asia Pacific (ASPAC), Europe, Middle East, Africa (EMEA), and the Americas.
Quality Operations (QO) manages validation/qualification of infrastructure and data platforms 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. Additionally, Quality Operations oversees the Quality Management Systems for Technology Services and Enterprise Functions and administers the Commercial Quality Shared Services functions of temperature control and transportation quality operations.
The Manager, Infrastructure is responsible for guiding and managing the team throughout the building and execution of quality into enterprise-wide systems, tools, services and infrastructure through the end-to-end lifecycle (design, develop, implement, maintain, retire). The Manager, Infrastructure will:
- Ensure that all J&J quality standards and global regulatory requirements are met
- Ensure building and execution activities involve early quality involvement in design and development, integrating quality into work products, implementing controls within applications/solutions, and leveraging automation when feasible
- Own the quality approach for systems and hold teams accountable for delivering an end-to-end support model
- Provide technical and procedural expertise/guidance to project teams, aligning with internal and external stakeholders
- Plan, allocate tasks and resources, execute, coordinate, and maintain validation activities for GxP systems/applications
- Support internal audits and Health Authority regulatory inspections
- Approve SDLC validation documentation deliverables, including release of system implementations/changes for production
- Attend project team meetings, offering EQ quality and compliance guidance and support
- Collaborate with globally diverse teams in an inclusive environment
- Promote an environment fostering the company’s credo and the value of a diverse workforce
- Develop and maintain an effective working partnership with senior management
- Collaborate with other leaders and staff within Quality Operations group to ensure each function is executed in an efficient manner
- Ensure timely reports of status, metrics and time sheets as required by the Quality Operations organization
- Ensure timely completion of assigned training and expense reports
- Serve as a trusted partner across the Enterprise Quality organization, fostering strong collaboration skills at the project team level, internally and externally
- Develop and maintain an effective working partnership with senior management
- Collaborate with other leaders and staff within Quality Operations group to ensure each function is executed in an efficient manner
- Ensure timely reports of status, metrics and time sheets as required by the Quality Operations organization
- Ensure timely completion of assigned training and expense reports
Qualifications
Requirements:
· A Bachelor’s degree in Computer Science, Information Systems, Business Administration or other related field required
· A minimum of 8 years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities is required
· A minimum of 3 years of experience with direct experience in stakeholder management
· Experience authoring or approving validation protocols, non-conformities, Change Requests, SOPs, Validation Plans and Reports is required
· Experience managing and leading global technology programs along with FTEs/consultant teams across multiple geographies
· Ability to make decisions by seeking out and maintaining trusting and collaborative relationships to meet business needs and demands
· 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 and validation
· Ability to work effectively in a highly matrixed team environment
· Experience in Testing Management tools like HPALM, JIRA with Xray, Selenium.
· Experience working on Network Automation Qualifications
· Experience in working to automated MLL Processes
· Ability to manage multiple and competing projects along with expert project management and organizational skills
· Knowledge of SDLC Quality Management process and Computerized System Validation/Computerized System Assurance principles
· Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820
Preferred:
· Experience in running large scale end-to-end Validation programs like LIMS, CAPA, MES, PLM, SAP, LMS, Complaints Handling, and Change Control is preferred
· Proficiency using the following tools is highly desirable: JIRA, HPALM, Xray, Jenkins, Selenium
· Direct experience working in a software development environment using Agile, SAFe, CI/CD is highly desirable
· Certified Software Quality Engineer (CSQE), Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Project Management Professional (PMP) or similar
· Working knowledge of other Global Regulations like EU Annex 11, SOX, HCC, Security & Privacy, ISO is preferred
· Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirable
· Knowledge of Software Quality Assurance and Software Quality Engineering is highly desirable
· Knowledge of the following technologies and methodologies highly desirable: Agile, SAFe, CI/CD, RPA, Cloud Storage and Computing, IoT, Data & Analytics, AI, Intelligent Automation, Blockchain, Kubernetes, XaaS, SaMD.
The base pay range for this position is $99,000 - $170,200.
This job posting is anticipated to close on May 24, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Employees are eligible for the following time off benefits:
- Vacation – up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
