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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
People Leader
All Job Posting Locations:
Bangalore, Karnataka, India, Chennai, Tamil Nadu, India, Pune, Maharashtra, India
Job Description:
Enterprise Quality(EQ) manages the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions for J&J. EQ 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 Leader of Systems & Infrastructure Assurance (Data Platforms), Enterprise Quality 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).
- This role must ensure that all J&J quality standards and global regulatory requirements are being met
- This role ensures that building and execution activities include early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and use of automation whenever feasible
- This individual will own the quality approach for systems and ensure teams are accountable for delivering on an end-to end support model for systems in scope
- The role provides technical and procedural expertise/guidance to the project teams as well as aligning with both internal and external stakeholders
- The role is responsible for planning, task and resource allocations, executing, coordinating and maintaining the validation activities for GxP systems/applications
- This position will support internal audits and Health Authority regulatory inspections
- This position will be responsible for the approval of SDLC validation documentation deliverables including the approval to release system implementation and/or changes for production use, will attend project team meetings and provide EQ quality and compliance guidance and support to project and base business support team members
- This role will lead globally diverse teams in an inclusive environment
- This role will provide an environment which encourages the company’s credo and the value of a diverse workforce.
- This role serves as a trusted partner across the Enterprise Quality organization, requiring strong collaboration skills at the senior leadership level, and includes making recommendations for improvements relevant to senior level stakeholders
Building and Execution of Quality into Applications and Supporting Infrastructure
- Ensures/promotes early involvement of EQ in the design and development of applications and infrastructure to ensure automated and preventive controls are built in
- Manages the end-to-end quality process and strategies for building and execution of applications and supporting infrastructure
- Ensures that all Enterprise Quality related projects go through the Intake process
- Provides strategic direction and operational support to the individual project teams
- Supports the building and execution of quality into Strategic Programs across the enterprise where the use of technology supported by EQ is involved
- Contributes to the creation of strategies for the qualification and validation of new and emerging technologies
- Provides compliance guidance and support to the project teams to ensure successful delivery of the project end-to-end
- Ensures a high degree of inspection readiness in support of health authority inspections, audits (internal and external) and periodic reviews of applications and infrastructure in scope of the EQ portfolio
- Participates in audits, approves audit non-conformity action plans, and approves closure of internal audit findings
- Assists with incident management/CAPA and NC for the systems supported
- Manages the execution of EQ tasks according to project plans, goals and timelines
- Supports the allocation of resources by accurately communicating availability
- Responsible for managing resources (both internal and external) and ensuring availability for ongoing and upcoming initiatives/projects
- Performs reviews and approval of validation deliverables, such as but not limited to Compliance Plans, User Requirements/User Stories, System Tests, User Acceptance Tests, Traceability Matrices, and Compliance Reports including final release and approval for production use
- Tracks and documents quantifiable business results achieved from project work and writes success stories for publication that demonstrate the business value created by EQ
- Manages Project budgets
- Collaborate with Data & Digital Strategy team from VCO to support execution of Data & Digital Strategy roadmap data integration, governance and emerging data needs
- Partners with Quality Management Systems team to execute defined strategies and provides input and feedback on the efficacy of the strategy, including any recommendations for improvements
- Partners with the EQ organization to train and implement new strategy for improvements
Stakeholder Management
- Partners with stakeholders to assess and implement compliant solutions to meet their business need
- Builds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and helps others to do the same
- Gains alignment on funding and support of the project with the Business Sponsor and/or Investment Owner
- Provides partnership, insight and direction to cross-functional business leaders and stakeholders regarding EQ policies, solutions, and initiatives
- Communicates proactively with stakeholders to set expectations on the feasibility and timeframe for the delivery of solutions and highlight the risks when quality standards are not met
Required Skills:
Preferred Skills:
Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Assessments, Standard Operating Procedure (SOP), Tactical Thinking, Team Management