Quality Assurance Associate at Immedica HQ

About the role

Immedica Pharma has experienced remarkable growth in recent years, and we are now looking for a Quality Assurance Associate to further strengthen our Global Quality Assurance department on our mission to make a difference in patients' lives by providing innovative therapies within rare diseases and specialty care.

At Immedica, patient safety is at the core of everything we do. The Global Quality Assurance department plays a critical role in ensuring that our products are manufactured, distributed, and handled in line with cGMP and cGDP requirements, contributing directly to patient well-being and regulatory compliance.

In this position, you will report to Head of Global Quality, Carina Carlsson, and be part of our collaborative and growing Global Quality team.

What you will be doing

This position is an excellent opportunity to grow and develop within Quality Assurance in a dynamic, entrepreneurial, and fast-growing Swedish company.

Your work will include:

• Acting as a subject matter expert for the product quality complaints process
• Managing the end-to-end handling of product quality complaints, including entry into the electronic Quality Management System (eQMS), coordination of investigations with manufacturers, and review and approval of investigation reports
• Serving as the primary QA contact with manufacturers and customers during complaint handling
• Performing related quality activities such as SOP updates, training of new employees, presenting processes during inspections and audits, and contributing to the management review
• Collaborating regularly with internal functions such as Regulatory Affairs, Pharmacovigilance, Medical Information, Manufacturing, Supply Chain, and Affiliates
• Working closely with external partners globally

In addition to complaints handling, the role also includes:

• Investigations of serialization alerts
• Management and evaluation of product returns
• Compilation of Product Quality Reviews
• Handling of deviations within the global supply chain
• Performing quality release for sale of batches at our central warehouse
• Ensuring timely and accurate responses to quality-related questions from the Immedica organization, external partners, and service providers

What you bring

To be considered for this role, you should have:

• Experience working with quality-related activities in the pharmaceutical industry, preferably for a minimum of two years
• A BSc or MSc in Pharmaceutical Sciences, Biomedicine or another similar field
• Fluency (spoken and written) in both Swedish and English

It is also considered an advantage if you have experience handling complaints within the pharmaceutical industry.

In addition, you are structured and detail-oriented in your way of working. To thrive in this role, we believe you are motivated by working in an environment characterized by its entrepreneurial spirit and drive.

Why this role at Immedica

At Immedica, you will be part of a growing pharmaceutical company focused on rare diseases and conditions with high unmet medical needs. You will join a small team that truly enjoys working together, where a positive work environment is highly valued and each person can, and should, bring their unique perspective.

We work across functions and markets, and people are given real responsibility in their roles. As the company grows, there are opportunities to learn, take on new challenges, and contribute beyond your immediate area. If you are looking for a workplace where you have a high degree of individual responsibility as well as close collaboration, you will find both here at Immedica, as they are essential to overcoming challenges and supporting patients across the globe.

We believe diverse perspectives strengthen our teams and help us better support patients globally. At Immedica, we are committed to fostering an inclusive workplace and welcome applications from candidates of all backgrounds, experiences, and perspectives.

How to apply

This is a full-time position based at our office in Torsplan, Stockholm. While this is a hybrid role, you are expected to work from the office regularly and should be based within commuting distance.

If you would like to be considered for the role, please submit your application through our system no later than June 30th. However, applications are reviewed on an ongoing basis, so we encourage you to apply as soon as possible.

About Immedica

Immedica is a pharmaceutical company headquartered in Stockholm, Sweden, focused on the commercialization of medicines for rare diseases and conditions with high unmet medical needs.

We are around 180 employees across Europe, the Middle East, and the United States, supporting patients in more than 50 countries.