Sr. Manager - IM CSV Quality Lead

Location: May be based at Beerse, Antwerp, Belgium; Cork, Ireland; Fuji, Japan; Geel, Belgium; Ghent, Belgium; Latina, Italy; Leiden, Netherlands; Raritan, New Jersey, United States; Schaffhausen, Switzerland; Wilson, North Carolina, United States; Xian, China, or another relevant J&J IM Supply Chain site.

Base pay: €96,000–€165,025 per year, depending on location and pay grade.

Company

Johnson & Johnson MedTech develops healthcare solutions and medical technologies across the global Johnson & Johnson organization.

What you will do

• Serve as the IM Quality point of contact for computer system validation and communicate significant quality and compliance issues to senior stakeholders.
• Implement the enterprise CSV framework, lifecycle validation standards, risk-based approaches, and system classification across Innovative Medicine.
• Oversee validation of GxP-relevant computerized systems from planning and design through testing, release, maintenance, and retirement.
• Ensure data integrity, ALCOA+ principles, Annex 11, FDA 21 CFR Part 11, Annex 22, and internal quality standards are applied consistently.
• Lead supplier qualification and monitoring, define validation effectiveness KPIs, and oversee system risk assessments and mitigation plans.
• Lead a global network of CSV leads and site SMEs, provide training, and support digital transformation, automation, digitization, and AI initiatives.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or a related field; a master’s degree is preferred.
• Extensive computer system validation experience in a GxP-regulated environment and experience in FDA/EMA GMP pharmaceutical operations.
• Strong knowledge of data integrity regulations, including Annex 11 and FDA 21 CFR Part 11; familiarity with ISO requirements.
• Generally 10+ years of combined experience in manufacturing, quality assurance, or quality control within the vaccines or pharmaceutical industry.
• Proven global or cross-site leadership experience, project management skills, and knowledge of quality systems including risk management, CAPA, change control, and document management.
• Strong communication, facilitation, collaboration, and stakeholder-management skills in complex matrix organizations.

Nice to have

• Master’s degree in a relevant discipline.
• Experience with modernization of validation approaches, including CSA, automation, digitization, or AI.
• Experience working across Quality Assurance, Quality Systems, IT, Digital and Technology, Manufacturing, QC, Engineering, and Data Integrity functions.

Culture & Benefits

• Inclusive work environment guided by the company’s Credo and focused on respect, diversity, and individual contribution.
• Annual bonus with a target based on pay grade and location, with actual awards linked to employee and company performance.
• Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and programs supporting financial, physical, and mental health.
• Service anniversary and recognition awards, plus eligibility for insurance plans subject to local plan terms.