QA Manager: Shape Quality Across Development to Manufacturing

QRIOS; Uppsala kommun; Hybrid; SEK 900,000 - 1,200,000; Full time

Job summary

Nanexa AB in Uppsala is seeking a QA Manager to shape and lead the quality function across development, manufacturing and clinical supply. You will drive QMS implementation and collaborate with development, production and analytics to ensure GMP-aligned processes throughout the product lifecycle.

The role combines strategic responsibility with hands-on work in a small, highly skilled team, offering the opportunity to influence QA across the organisation and contribute to Nanexa's growth.

Qualifications

• Several years of QA experience in GMP-regulated pharmaceutical or biotech environment.
• Experience in development and/or validation of manufacturing or analytical processes.
• Experience in authoring and reviewing GxP-critical documentation, including SOPs, deviations, CAPAs and change controls.
• Strong knowledge of Quality Systems and applicable GMP regulations.
• Fluency in Swedish and English.

Responsibilities

• Develop, implement and continuously improve the Quality Management System.
• Oversee manufacturing and analytical activities from development to clinical supply.
• Review SOPs, manage periodic reviews and support supplier qualification and re-evaluation.
• Lead and participate in internal audits and audits of external service providers.
• Represent QA in cross-functional project teams and contribute to project execution.
• Provide guidance and support to the organisation in quality-related matters.
• Perform internal training within GMP and quality systems.
• Contribute to the strategic development of the QA function and quality processes.

Skills

QA experience

GxP documentation

Quality Systems

Regulatory compliance

SwedishEnglish fluency

Cross-functional collaboration

Education

MSc in Pharmacy

MSc in Biology

MSc in Chemistry

MSc in Engineering

Related field

Job description

Nanexa AB in Uppsala is seeking a QA Manager to shape and lead the quality function across development, manufacturing and clinical supply. You will drive QMS implementation and collaborate with development, production and analytics to ensure GMP-aligned processes throughout the product lifecycle.

The role combines strategic responsibility with hands-on work in a small, highly skilled team, offering the opportunity to influence QA across the organisation and contribute to Nanexa's growth.