QA CSV and Data Integrity Expect

Location: Gent or Beerse, Belgium

Base pay: €60,000–€96,255 per year

Company

Johnson & Johnson MedTech develops healthcare, innovative medicine, and medical technology solutions.

What you will do

• Provide quality oversight for computer system validation and data integrity in manufacturing and laboratory areas.
• Ensure CSV regulatory requirements are fulfilled throughout the complete computerized-system life cycle.
• Act as process owner for computer system validation management and review or approve CSV documentation.
• Prepare for and represent CSV matters during audits and inspections, and follow up on internal and external audits.
• Advise engineering, IT, and cross-functional teams on CSV activities and cGMP requirements for new systems and projects.
• Serve as a subject-matter expert for data integrity topics and maintain knowledge of evolving regulations and guidelines.

Requirements

• Master’s degree in a scientific field or equivalent experience.
• At least 3 years of experience in the pharmaceutical industry.
• Knowledge of cGMP/CSV compliance, including 21 CFR Parts 11, 210, and 211, EU requirements, Annex 11, GAMP, and data integrity guidelines.
• Experience with computerized system validation and the ability to make risk-based quality decisions.
• Fluent written and spoken English and Dutch required.
• Strong ownership, quality focus, communication skills, and ability to deliver against commitments.

Culture & Benefits

• Inclusive work environment focused on diversity, dignity, and individual merit.
• Annual performance-based bonus or sales commissions, depending on the role and location.
• Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Insurance plans, service anniversary awards, and recognition awards may be available under applicable plans.

Hiring process

• CV review followed by a short recruitment call for suitable candidates.
• Successful candidates complete country-specific checks before starting.
• Candidates are invited to provide feedback through a short survey after the process.