Sr. Manager

h3Job Description /h3pThe 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 JJ quality standards. /ppThe 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. /ph3Key Responsibilities /h3pThe Sr. Manager
- IM Computer System Validation Quality Lead is accountable and responsible for; /pulliActing 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. /li /ulh3IM CSV Strategy Governance /h3ulliOnboards and supports the JJ enterprise CSV framework in IM aligned with regulatory expectations and internal quality systems, /liliDeploys standards for lifecycle validation, risk-based approaches, and system classification across IM, /liliEnsure consistent interpretation and application of Annex 11 requirements across sites, /liliDrive harmonization of CSV practices across IM and business units. /li /ulh3Lifecycle Validation Oversight of all IM GxP-relevant computerized systems /h3ulliValidated prior to use, /liliMaintained in a validated state throughout their lifecycle, /liliProperly retired/decommissioned, /liliOversee validation activities across IM system lifecycle (planning → design → testing → release → maintenance), /liliDefine and monitor KPIs for validation effectiveness and compliance. /li /ulh3Data Integrity Compliance /h3ulliEnsure implementation of data integrity principles (ALCOA+) across all systems and processes, /liliEnsure compliance with JJ CSV and Data Integrity standards. /li /ulh3Risk-Based Validation QRM /h3ulliDefine and enforce risk-based validation approaches using Quality Risk Management (QRM), /liliEnsure appropriate validation effort proportional to system criticality and GxP impact, /liliOversee system risk assessments and mitigation strategies in IM. /li /ulh3IM System Lifecycle Technical Compliance /h3ulliGuides and oversees System Development Lifecycle (SDLC) / System Lifecycle Management (SLCM) activities (incl. system periodic review activities and follow-ups). /li /ulh3Supplier Third-Party Oversight /h3ulliOnboards and supports the JJ enterprise process for supplier assessment and CSV deliverables, /liliOversees qualification and monitoring of IM system providers. /li /ulh3Organizational Leadership Capability Building /h3ulliLead a global network of CSV leads / site SMEs, /liliProvides training for IM CSV roles, /liliProvide expert guidance to IM projects, digital initiatives, and innovation programs, /liliPromote a culture of compliance, quality, and continuous improvement. /li /ulh3Continuous Improvement Innovation /h3ulliSupports JJ enterprise teams to drive modernization of validation approaches (e.g., CSA, automation, digitization, AI), /liliIdentify opportunities to streamline validation while maintaining compliance, /liliAlign IM CSV strategy with digital transformation initiatives. /li /ulh3Training /h3ulliDevelop and deploy fit for purpose CSV training in IM. /li /ulpThe 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. /ph3Qualifications /h3ulliA minimum of University/Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field. Master’s degree is preferred. /liliExtensive experience in CSV within a GxP-regulated environment. /liliProven 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. /liliGenerally 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. /liliProven leadership experience in global or cross-site roles. /liliWorking knowledge of Quality systems such