Quality Assurance (QA) Manager to Nanexa AB

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 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.

Your responsibilities will include:

• - 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 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

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.

About Nanexa AB

Nanexa is a Swedish pharmaceutical company developing long‑acting injectable drugs based on our proprietary PharmaShell® technology. We operate at the intersection of material science and drug development, taking projects from early idea through development to proof‑of‑concept in clinical trials. In addition to our own pipeline, we collaborate with leading pharmaceutical companies to develop new products based on our technology. To learn more about Nanexa, please visit www.nanexa.com