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Senior Manager, IT Quality Assurance

2 months ago

Raritan, New Jersey, United States Johnson and Johnson Full time

Johnson & Johnson is seeking a Senior Manager, IT Quality Assurance to join our team.

At Johnson & Johnson, we are committed to advancing health and well-being. Our leadership in healthcare innovation enables us to create a future where complex health challenges are addressed effectively, treatments are personalized, and solutions are more efficient. With our expertise in Innovative Medicine and MedTech, we are poised to lead the way in healthcare advancements that will transform lives.

For over 130 years, our dedication to diversity, equity, and inclusion (DEI) has been integral to our culture and operations. Grounded in Our Credo, our DEI values drive our mission to foster a healthier, more equitable world. We believe that a diverse workforce and a culture of belonging are essential for innovation, allowing us to tackle the most pressing healthcare issues. At Johnson & Johnson, we prioritize an inclusive environment where every voice is heard and valued.

The Senior Manager, IT Quality Assurance will spearhead the quality strategy for IT systems, encompassing applications, infrastructure, and digital health solutions. The Technology Quality & Compliance (TQ&C) team serves as the Quality Unit and Subject Matter Expert for the validation and qualification of both applications and infrastructure, ensuring adherence to our Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework. This role is crucial in maintaining compliance with global regulations, providing quality guidance, and addressing compliance gaps identified during audits and inspections.

The responsibilities of the Senior Manager, IT Quality Assurance include:

  • Leading and managing the team to integrate quality into enterprise-wide systems, tools, services, and infrastructure throughout their lifecycle (design, develop, implement, maintain, retire).
  • Ensuring compliance with all Johnson & Johnson quality standards and global regulatory requirements.
  • Facilitating early involvement of quality in design and development processes, embedding quality into deliverables, and implementing controls within applications/solutions.
  • Owning the quality strategy for systems and ensuring accountability for an end-to-end support model.
  • Providing technical and procedural expertise to project teams while collaborating with internal and external stakeholders.
  • Planning, allocating resources, and coordinating validation activities for GxP systems/applications.
  • Supporting internal audits and regulatory inspections.
  • Approving SDLC validation documentation and participating in project team meetings to offer quality and compliance guidance.
  • Fostering an inclusive environment that aligns with the company's credo and values diversity.
  • Building trusted partnerships across the Technology Quality & Compliance organization, requiring strong collaboration skills.
Education:
  • A Bachelor's degree in Computer Science, Information Systems, Business Administration, Engineering, or a related field is required.
Experience and Skills:

Required:
  • Four to six (4-6) years of relevant experience.
  • Progressive experience in the pharmaceutical, medical device, or biotech sectors, with direct involvement in Computerized System Validation activities.
  • Experience in authoring or approving Validation Plans, Reports, Requirements/User Stories, validation protocols, non-conformities, Change Requests, and SOPs.
  • Familiarity with testing tools and experience in a fast-paced CI/CD environment, utilizing tools such as qTest, JIRA, Xray, Selenium, GitHub, Bitbucket, and Artifactory.
  • Quality oversight and/or technical experience in technologies such as Cloud Storage & Computing, Virtual Private Clouds (VPCx), Infrastructure as Code, Containers Services, IoT, XaaS, Data & Analytics, AI, Intelligent Automation, and Blockchain.
  • Experience with identity and access management and other security-related tools.
  • Solid understanding of PMO, SDLC, GAMP 5, and ITIL frameworks.
Preferred:
  • Prior experience in comprehensive technology qualification programs supporting infrastructure and enabling tools.
  • Knowledge or certifications in Software Quality Assurance and Software Quality Engineering.
  • Experience in large-scale technology validation programs such as LIMS, CAPA, MES, PLM, SAP, LMS, Complaints Handling, and Change Control.
  • Direct experience in a software development environment utilizing Agile, SAFe, CI/CD, or similar methodologies.
Other:
  • Additional certifications are a plus.
For more information on how we support the overall health of our employees throughout their wellness, career, and life journey, please visit our website.

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.