Sr. Manager

Job Description

The IM Computer System Validation (CSV) Quality Lead is responsible for assessing, implementing, and continuously improving the IM strategy for computer system validation and the use of embedded AI technology supporting GxP-regulated activities. This role ensures oversight that all IM systems are validated and maintained in a validated state and are NOT using prohibited AI technology throughout their lifecycle, in alignment with global regulatory requirements (e.g., EU GMP Annex 11, FDA 21 CFR Part 11, Annex 22) and J&J quality standards. The role inventories all IM systems, embedding the collection as an integral of the QMS. It provides direction, oversight, and strategic direction across IM and platforms, ensuring consistent application of risk-based validation approaches, proper AI technology usage, robust data integrity practices (ALCOA+), and lifecycle management of computerized systems. Key Responsibilities

The Sr. Manager - IM Computer System Validation Quality Lead is accountable and responsible for; Acting as IM Quality single point of contact for CSV, ensuring appropriate and timely communication of significant/critical quality and compliance issues linking to Computer System Validation and making recommendations for improvements to relevant senior level stakeholders. IM CSV Strategy & Governance

Onboards and supports the J&J enterprise CSV framework in IM aligned with regulatory expectations and internal quality systems, Deploys standards for lifecycle validation, risk-based approaches, and system classification across IM, Ensure consistent interpretation and application of Annex 11 requirements across sites, Drive harmonization of CSV practices across IM and business units. Lifecycle Validation Oversight of all IM GxP-relevant computerized systems

Validated prior to use, Maintained in a validated state throughout their lifecycle, Properly retired/decommissioned, Oversee validation activities across IM system lifecycle (planning → design → testing → release → maintenance), Define and monitor KPIs for validation effectiveness and compliance. Data Integrity & Compliance

Ensure implementation of data integrity principles (ALCOA+) across all systems and processes, Ensure compliance with J&J CSV and Data Integrity standards. Risk-Based Validation & QRM

Define and enforce risk-based validation approaches using Quality Risk Management (QRM), Ensure appropriate validation effort proportional to system criticality and GxP impact, Oversee system risk assessments and mitigation strategies in IM. IM System Lifecycle & Technical Compliance

Guides and oversees System Development Lifecycle (SDLC) / System Lifecycle Management (SLCM) activities (incl. system periodic review activities and follow-ups). Supplier & Third-Party Oversight

Onboards and supports the J&J enterprise process for supplier assessment and CSV deliverables, Oversees qualification and monitoring of IM system providers. Organizational Leadership & Capability Building

Lead a global network of CSV leads / site SMEs, Provides training for IM CSV roles, Provide expert guidance to IM projects, digital initiatives, and innovation programs, Promote a culture of compliance, quality, and continuous improvement. Continuous Improvement & Innovation

Supports J&J enterprise teams to drive modernization of validation approaches (e.g., CSA, automation, digitization, AI), Identify opportunities to streamline validation while maintaining compliance, Align IM CSV strategy with digital transformation initiatives. Training

Develop and deploy fit for purpose CSV training in IM. The candidate will interface with various stakeholders not limited to Quality Assurance / Quality Systems / IT / Digital & Technology organizations / Manufacturing / QC Analytical Instrument Qualification / Engineering / Data Integrity & Compliance. Qualifications

A minimum of University/Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field. Master’s degree is preferred. Extensive experience in CSV within a GxP-regulated environment. Proven knowledge of applicable Data Integrity regulations (Annex 11 / 21 CFR Part 11) is required. Working experience within an FDA/EMA GMP (Pharmaceutical) regulated environment is required. Familiarity with ISO requirements. Generally requires 10+ combined years of experience in Manufacturing, Quality Assurance, Quality Control, in vaccines/pharmaceutical industry. Solid understanding of the business environment inside a quality organization, across various roles (e.g., quality operations, quality control, quality systems, etc.) is preferred. Proven leadership experience in global or cross-site roles. Working knowledge of Quality systems such as: Risk Management, Investigation/CAPA, Change Control, Document Management, Management Review process, etc. required. Quality mindset and ability to enable Critical &