Sr Analyst, Digital Core

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 Systems

Job Category:
Professional

All Job Posting Locations:
Bangalore, Karnataka, India, Beerse, Antwerp, Belgium, Mumbai, India, Raritan, New Jersey, United States of America, Singapore, Singapore

Job Description:

Johnson & Johnson is currently recruiting for a Sr Analyst, Digital Core to be locatedin Bangalore, India .

About MedTech

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at

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.
Key Responsibilities:

• Ensure early EQ involvement in application and infrastructure design/development so automated and preventive controls are built in from the start.
• Own and lead the end-to-end quality process and strategy, providing compliance guidance for applications and supporting infrastructure.
• Provide strategic direction and operational support to project teams and manage execution of TQ tasks to meet project plans, goals and timelines.
• Develop and contribute to qualification and validation strategies for new and emerging technologies.
• Maintain inspection readiness for health-authority inspections, internal/external audits and periodic reviews; participate in audits and approve non-conformity action plans and closures.
• Support incident management, CAPA and non-conformance resolution for systems in scope.
• Review and approve validation work and sign off on releases to production (Compliance Plans, User Requirements/User Stories, System Tests, UAT, Traceability Matrices, Compliance Reports, etc.).
• Proactively monitor systems and processes for alignment to SOPs and industry guidelines; collaborate with the EQ Manager to manage project costs, schedules, resources and quality.
• Partner with cross-functional team members to implement compliant solutions, set expectations, communicate feasibility/timeframes, and highlight quality risks.
• Lead and mentor people: provide quality guidance, apply risk-based validation approaches, manage consultants/vendors, nurture future leaders and ensure resource availability for initiatives.

This role builds and sustains a strong, collaborative partnership with senior management and works closely with leaders and staff across the EQ group to streamline functions and drive operational efficiency.

Education

• Bachelor's or equivalent degree in Computer Science, Information Systems, Business Administration, Science, Engineering or another related field is required.

Experience and Skills
Required:

• 2-4 years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities
• 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
• Solutions oriented, aiming for new ways to accomplish goals and pragmatic advising ensuring compliance in a cost-effective and risk-based manner
• Ability to manage multiple and competing projects
• Gives input and ensures adoption for how quality will be designed into/maintained and understands data integrity needed throughout the lifecycle within a technology solution
• Defines strategy for testing according to the risk assessment
• Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820
• Experience validating Testing Management tools like qTest, Jira with Xray and security tools such as Identity and Access Management and OT security tools
• Experience working in a fast paced CICD environment with tools like Jenkins, GitHub, Bitbucket and Artifactory
• Experience working as Cloud software Quality - Virtual Private Clouds (VPCx), Cloud Storage and Computing, Containers services/Kubernetes, Chef etc.

Preferred:

• Implements elements of an effective quality management system to the organization and its technology solutions
• Aware of cybersecurity and privacy principles and implications for quality and risk management activities
• Applies best practices for security role design and segregation of duties within and across technology solutions
• Understands how to prepare an organization and business partners for audits and inspections
• Able to apply digitization tools and techniques to automate, simplify, digitize and enhance software development and validation processes
• Knowledge of SDLC Quality Management process and CSV/CSA principles
• Working knowledge of other Global Regulations like EU Annex 11, SOX, HCC, Security & Privacy, ISO
• Solid understanding of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirable
• Knowledge of the following technologies and methodologies is preferred: Agile, SAFe, RPA, IoT, Data & Analytics, AI, Intelligent Automation, Blockchain.

Other:

• Proficiency in the English language, both written and oral, is required
• Up to 10% travel both international and domestic may be required

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law.

Required Skills:

Preferred Skills:
Analytical Reasoning, Business Alignment, Business Behavior, Coaching, Collaborating, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Systems Analysis, Training People