Sr. Manager - IM CSV Quality lead

Johnson & Johnson Innovative Medicine; Oost-Vlaanderen; Sur place; EUR 96 000 - 165 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine is seeking an IM CSV Quality Lead to define validation strategy for computer systems and embedded AI in a GxP setting. You will ensure validation, lifecycle maintenance, and compliance with EU Annex 11 and FDA 21 CFR Part 11 across IM systems.

You will lead a global network of CSV leads, drive risk-based validation, data integrity, and QRM, and mentor teams while advancing modernization of validation approaches and AI governance.

Qualifications

• University/Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field.
• 10+ years of combined experience in Manufacturing, Quality Assurance, Quality Control in vaccines/pharmaceutical industry.
• Extensive CSV experience in a GxP-regulated environment.
• Proven knowledge of Data Integrity regulations (Annex 11 / 21 CFR Part 11).
• Leadership experience in global or cross-site roles.

Responsabilités

• Act as IM CSV single point of contact for CSV and compliance issues; communicate with senior stakeholders.
• Onboards and supports the CSV framework for IM; deploys lifecycle validation standards and risk-based approaches.
• Oversee validation activities across system lifecycle (planning→ design→ testing→ release→ maintenance).
• Define and monitor KPIs for validation effectiveness and compliance.
• Ensure data integrity (ALCOA+) across all systems and processes.
• Lead a global network of CSV leads; provide training and mentorship.

Connaissances

CSV in GxP

Quality systems

Risk management

Project management

Communication skills

Global / cross-site leadership

Formation

Bachelor’s degree in Life Sciences or related

Master’s degree preferred

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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

Beerse, Antwerp, Belgium, Cork, Cork, Ireland, Fuji, Shizuoka-Ken, Japan, Geel, Antwerp, Belgium, Ghent, East Flanders, Belgium, Latina, Italy, Leiden, Netherlands, Raritan, New Jersey, United States of America, Schaffhausen, Switzerland, Wilson, North Carolina, United States of America, Xian, Shaanxi, China

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.

This position may be based at any of the listed locations or another relevant J&J IM Supply Chain site.

Key Responsibilities

• 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 & Design Thinking.
• Project Management skills and experiences. Knowledge of Project methodologies and process excellence.
• Strong communication (verbal, written, and presentation) and interpersonal skills, self-awareness and adaptability required.
• Strong facilitation skills and ability to build respectful and productive partnership relationships with peers. Independent thinking. Pragmatism. Ability to zoom-in and out.
• Working experience in navigating and dealing effectively within a matrix organization, managing complexity, engaging and collaborating with multi-disciplined teams across boundaries including remote team members.
• Results oriented with strong track record of success in delivering on objectives. Sense of urgency and ability to zoom-in / zoom out.

Preferred Skills

Analytical Reasoning, Analytics Dashboards, Compliance Management, Data Gathering and Analysis, Data Quality, Incident Management, Organizing, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Risk Management, Standard Operating Procedure (SOP), System Integration, Systems Analysis, Tactical Planning, Technical Credibility

The Anticipated Base Pay Range For This Position Is

€96 000,00 - €165 025,00

Benefits

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.