Radiopharmaceutical QA Lead - Batch Release & Compliance

Novartis AG; Baarle-Nassau; On-site; EUR 56,000 - 104,000; Full time

Benefits offered by this job

Hybrid working options

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

14 weeks parental leave

Job summary

Novartis AG in Baarle-Nassau, The Netherlands, seeks a Qualified Person to oversee batch release, ensure product quality, and maintain GMP-compliant systems. This onsite, full-time role requires deep QA expertise and a proactive, hands-on approach to regulatory compliance.

You will review batch analyses, support supply chain reliability, lead investigations into deviations and CAPAs, and act as SME during inspections. Fluent English and a Master’s degree are required, with 3+ years in pharma QA.

Qualifications

• Master's degree in a scientific discipline; Pharmacy preferred.
• 3+ years of experience in a similar QA role within pharma/biotech.
• Strong knowledge of GMP and applicable pharmaceutical regulations.
• Hands-on and proactive working style with ownership.
• Agile mindset with clear priorities and collaborative approach.
• Fluent in English, written and spoken.

Responsibilities

• Release batch analyses on site to support reliable product supply.
• Provide quality oversight for site operations and quality management activities.
• Write, review, and approve GMP documentation and procedures.
• Act as SME during health authority inspections, audits, and internal reviews.
• Investigate deviations, CAPAs, changes, and product quality complaints.
• Coach and train staff on cGMP requirements and best practices.
• Deputize for the Quality Operations Manager when required.

Job description

Novartis AG in Baarle-Nassau, The Netherlands, seeks a Qualified Person to oversee batch release, ensure product quality, and maintain GMP-compliant systems. This onsite, full-time role requires deep QA expertise and a proactive, hands-on approach to regulatory compliance.

You will review batch analyses, support supply chain reliability, lead investigations into deviations and CAPAs, and act as SME during inspections. Fluent English and a Master’s degree are required, with 3+ years in pharma QA.