QA Manager – Diamyd Medical, Umeå

Are you ready to lead QA in an advanced biologics facility? Here is your opportunity to influence operations, ensure compliance, and drive strategic impact in precision medicine. 

Haeger & Carlsson Executive Search and Interim is proud to support Diamyd Medical in recruiting a Quality Assurance (QA) Manager with Qualified Person (QP) Responsibility for their state-of-the-art Biologics Manufacturing facility in Umeå.

As QA Manager with QP Responsibility, you will play a key role in planning, leading, and developing Quality Assurance activities at the Umeå manufacturing site. Your mission will be to ensure that all operations are performed in compliance with GMP and regulatory requirements — enabling safe and effective production of critical biologics.

We are looking for a candidate who combines strong leadership skills with deep technical expertise in QA. You thrive in a collaborative, fast-paced environment, can manage complex projects, and can inspire and develop your team. You are proactive, detail-oriented, and capable of translating regulatory requirements into practical solutions, ensuring both compliance and operational excellence.

Diamyd Medical develops precision medicine therapies for Type 1 Diabetes. The drug candidate, Diamyd, is an antigen-specific immunotherapy for the preservation of endogenous insulin production. DIAGNODE-3, a confirmatory Phase III trial is actively recruiting patients with recent-onset Type 1 Diabetes in eight European countries and in the US. A biomanufacturing facility is being set up in Umeå for the manufacture of recombinant GAD65, the active ingredient in the antigen-specific immunotherapy Diamyd. The long-term goal for the facility is to produce enough GAD65 to meet the market demand for Diamyd, as well as to be a key player in the production of biological substances for other drug projects.

Diamyd Medical lives by its core values: Innovation, Teamwork, Resilience, and Compassion — principles that shape how the company collaborates, finds solutions, and drives progress in its field.

Read more:
Diamyd Medical Manufacturing Site Umeå

Key responsibilities:

• Lead and manage the QA department, including budget responsibility, line management of QA personnel, performance reviews, and development discussions

• Hold or delegate QP responsibility for final review and Drug Substance batch release according to GMP and Manufacturing Authorization requirements
  

• Represent QA as a member of the local Umeå site management team
  

• Plan, coordinate, and monitor QA activities in line with project plan

• Develop, implement, and ensure completion of GMP training programs for all manufacturing site personnel

• Overall responsibility for QMS and eQMS systems, including oversight, continuous review, and improvement of procedures and processes

• Assess critical and major deviations, including CAPA management, and follow up on corrective actions

• Assess change control cases with potential impact on regulatory, operational, or authorization status

• Oversee and follow up on any outsourced QA activities

Key Requirements:

• M.Sc. or PhD in pharmacy, biotechnology, bioengineering, biomedical sciences, or a similar discipline

• Experience in QA within GMP-regulated manufacturing

• Leadership experience with line management or project leadership responsibility

• Previous experience as a QP and fulfilling the requirements as defined in Article 48 of Directive 2001/83/EC, as amended, and Article 52 of Directive 2001/82/EC

• Proven experience with QMS/eQMS systems, including implementation, maintenance, and continuous improvement

• Experience developing and implementing GMP training programs

• Experience with deviation handling, CAPA, change control processes, and regulatory impact assessments

• Experience overseeing outsourced QA activities or managing external partners/vendors

• Strong ability to plan, prioritize, and communicate effectively

• Fluent in spoken and written Swedish and English

This is a unique opportunity to join a growing company and play a central role in the establishment of a new biomanufacturing facility. If you are a driven and experienced QA professional with QP qualifications and a passion for leading high-performing teams in a dynamic biotech environment, we welcome your application.

Please apply through haegercarlsson.com

Questions are answered by:

Anna Freese +46 (0)76-174 75 81, anna.f@haegercarlsson.com