Quality Assurance (QA) Manager to Nanexa AB
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
FOR MORE INFORMATION ABOUT THE POSITION, PLEASE CONTACT:
Krishan Johansson Haque, PhD
Sr Recruitment Consultant, QRIOS Life Science & Engineering
T: +46 (0)72-070 16 53
E: krishan.johansson-haque@qrios.se