Quality Assurance (QA) Manager to Nanexa AB

QRIOS AB; Uppsala kommun; On-site; SEK 540,000 - 720,000; Full time

Job summary

Nanexa is seeking a Quality Assurance (QA) Manager to join our headquarters in Uppsala. This full-time position offers a unique opportunity to build and shape our quality function in a dynamic pharmaceutical environment.

The ideal candidate will have a Master's degree and substantial QA experience in a GMP-regulated setting, contributing directly to our Quality Management System and collaborating across various departments.

Qualifications

• Several years of experience within QA in a 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.

Responsibilities

• Develop, implement and continuously improve the Quality Management System.
• Assess and approve batch-related documentation.
• Ensure production and testing of clinical trial materials comply with GMP requirements.

Skills

Fluency in Swedish

Fluency in English

Strong knowledge of Quality Systems

Experience in GMP-regulated environment

Proactive and structured approach

Education

MSc in Pharmacy, Biology, Chemistry, Engineering, or related field

Job description

Nanexa is now recruiting a Quality Assurance (QA) Manager. The position is full-time and based at our headquarters in Uppsala, and we are looking for a new colleague to join our growing organisation.

As a QA Manager at Nanexa, you will play a key role in building and shaping the quality function in a growing pharmaceutical company. This is not a traditional QA role in a large organisation – instead, you will be part of a small, highly skilled team where your contributions will have a direct and visible impact on how we work and grow. You will have the opportunity to develop, implement and continuously improve our Quality Management System while being actively involved in the full product lifecycle – from early development to manufacturing of clinical trial material. The role combines strategic responsibility with hands‑on work and close collaboration across functions.

At Nanexa, you will not work in a silo. You will be involved across the organisation, working closely with colleagues in development, production and analytics, gaining a broad understanding of our technology, products and processes. As a company of approximately 15 employees, we offer an environment where each individual plays an important role, and where you will actively contribute to building something new.

Responsibilities

The QA Manager will have a central role in the oversight of manufacturing and analytical activities from a quality perspective, covering the entire chain from development to clinical supply. You will report directly to the Head of Quality Assurance and be an important contributor to the continued development of the QA function and the company as a whole.

• Develop, implement and continuously improve the Quality Management System in line with company growth and regulatory requirements
• Assess and approve batch‑related documentation such as specifications, batch records, deviations and change requests
• Ensure that production and testing of clinical trial materials are conducted in accordance with applicable GMP requirements
• Review and approve 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

Your Profile

We are looking for a driven and quality‑minded professional who enjoys working in a dynamic and developing environment.

Key qualifications include:

• MSc in Pharmacy, Biology, Chemistry, Engineering, or a related field
• Several years of experience within QA in a GMP‑regulated pharmaceutical or biotech environment
• Experience in development and/or validation of manufacturing or analytical processesExperience in authoring and reviewing GxP‑critical documentation, including SOPs, deviations, CAPAs and change controlsStrong knowledge of Quality Systems and applicable GMP regulationsFluency in Swedish and English

  As a person, you are proactive, structured and solution‑oriented, with a strong sense of ownership and accountability. You thrive in a dynamic organisation where processes are still being developed, and where you have the opportunity to make a real impact. You are comfortable taking on multiple responsibilities and enjoy working both independently and in close collaboration with others.

  At Nanexa, each employee contributes to the overall success of the company and you will have the opportunity to influence not only your own area of responsibility, but also the development of the company as a whole.