Lead, Digital Core

Role Summary

Lead, Digital Core role focused on quality and compliance for IT systems within Johnson & Johnson's Enterprise Quality (EQ) group. You will own the end-to-end quality process and strategy for applications and supporting infrastructure, providing guidance to project teams and validating new technologies. The position emphasizes risk-based validation, regulatory alignment, and collaboration with cross-functional partners to ensure inspection readiness and continuous improvement.

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.

Qualifications

• Required: 2–4 years of progressive experience in the pharmaceutical/medical device/biotech industry, with direct experience in Computerized System Validation activities.
• Required: Ability to work independently with a broad range of quality and validation tasks; strong self-management.
• Required: Solutions-oriented with pragmatic, compliant, cost‑effective approaches; capable of managing multiple projects.
• Required: Understanding of data integrity throughout the lifecycle within technology solutions; ability to design quality into solutions.
• Required: Knowledge of testing strategy and risk-based approaches; thorough knowledge of cGMP CSV regulations (e.g., 21 CFR Part 11, Part 210, Part 211, Part 820).
• Required: Experience validating Testing Management tools (e.g., qTest, Jira with Xray) and security tools (Identity and Access Management, OT security).
• Required: Experience in a fast-paced CI/CD environment with tools such as Jenkins, GitHub, Bitbucket, and Artifactory.
• Required: Experience with cloud software quality (VPCs, cloud storage/computing), containers/Kubernetes, and related technologies (Chef, etc.).

Skills

• Analytical Reasoning
• Business Alignment
• Quality Management and Compliance
• Documentation and Data Quality
• Problem Solving and Quality Auditing
• Quality Control (QC) and Quality Management Systems (QMS)
• Systems Analysis and Training

Education

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

Additional Requirements

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