Haeger&Carlsson Executive Search and Interim is now recruiting a proactive and hands-on QA Specialist to join Diamyd Medical’s Biologics Manufacturing facility in Umeå.

Diamyd Medical develops precision medicine therapies for Type 1 Diabetes. 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^®.

In this role, you will play a crucial role in ensuring compliance with regulatory requirements and maintaining high-quality standards. As a member of the QA team, you are expected to contribute to and develop parts of the quality system according to EU and FDA GMP guidelines, for example by shaping and implementing GMP-compliant processes and documentation. You will perform QA review and release of ingoing materials and process-steps, and the role includes participation in the setting up and maintenance of batch documentation routines – from GMP-compliant master batch records to templates, as well as procedures for how batch records are issued and handled. You will work in cross-functional teams, with colleagues at the manufacturing site but also with colleagues in R&D functions. You will report to the QA Manager and the role is based in Umeå.

This is a broad and hands-on role suited for someone who enjoys variety, takes initiative, and thrives in environments where structures are still being developed. The ideal candidate has several years of experience in pharmaceutical manufacturing and review and release processes and is comfortable working both independently and in cross-functional teams. A background from a smaller or growing organization—where you’ve contributed to building routines and quality systems—is particularly valuable. Experience with drug substance manufacturing is a strong advantage, but similar experience from other regulated industries such as medtech, food, or cosmetics is also relevant.

Key responsibilities

• Review and approve Master batch records, SOPs, Specifications and other controlling documents, to ensure accuracy, completeness and compliance.

• Review and release ingoing materials based on quality documentation.

• Review Batch manufacturing records and analytical results from manufacturing of both intermediate process steps and the final Drug Substance.

• Develop, maintain, monitor, and contribute to continuous improvements of the quality management system to ensure that regulatory requirements are met.

• QA role in the setting up and maintenance of batch documentation routines, templates and defining procedures for the issuing, managing and reviewing of batch records.

• Handle and/or lead investigations/actions of deviations, changes and CAPAs.

• Be a QA support in the set-up and qualification of equipment as well as validation and implementation of process steps and procedures.

• Participate in regulatory inspections.

Key Requirements

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

• Several years’ experience within QA, preferably working in a GMP environment.

• Proficient in quality review and release procedures.

• Proficient in quality systems.

• Strong organizational skills.

• Ability to work both independently and as part of a team.

• Collaborative mindset with a genuine willingness to support and engage with colleagues.

• Strong communication skills, both verbal and written.

• Fluency in English, both written and spoken, is required. The ability to communicate clearly in Swedish, both verbally and in writing, is also required.

This is a great opportunity to contribute to building quality processes at an exciting company in a dynamic development phase. If you’re looking for a position where your ideas and experience will truly make a difference, we look forward to your application!

Please apply through haegercarlsson.com
Questions are answered by:

Anna Freese +46(0)76-174 7581, anna.f@haegercarlsson.com
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