Quality Manager

About us:

At PrecisionPhage, we are on a mission to transform healthcare with bacteriophage-based solutions that address the escalating threat of antibiotic resistance. As a cutting-edge startup at the intersection of biotechnology and data science, we are developing advanced bioinformatics software to analyse key information from genomic data. We are now looking for an experienced Quality Manager to be our first dedicated quality professional, playing a crucial role in setting up and maintaining quality systems for our innovative solutions.

Why join us?

Join a team dedicated to tackling one of the world’s most pressing healthcare
challenges – antibiotic resistance. You will be a core part of a growing team and
shape the future of our company’s quality management and get to work alongside industry
experts and scientists pushing the boundaries of biotech.

Role overview:

As our Quality Manager, you will be involved in building and implementing quality processes from the ground up and ensuring compliance with an initial focus on our bioinformatics software. The ideal candidate will have a strong background in pharmaceutical and medical device regulation, CE certification process, software quality management, relevant standards and certifications (including audits) with understanding of bioinformatics or a related field. This position will give you a unique opportunity to build and lead quality efforts and help us in our mission of combating antibiotic resistance.

The position is partly remote, partly on-site meetings and work in Jyväskylä OR Turku. Therefore, we particularly focus on applications from people residing in Jyväskylä OR Turku regions.

Key responsibilities:

• With our executive team, develop, refine, execute & update a comprehensive quality strategy.
• With our company executives, design and establish a quality management system (QMS) tailored to required quality requirements.
• Help to create, maintain and update quality protocols, testing methodologies, and validation processes for a bioinformatics software analysing genome data.
• Develop risk management, SOPs, guidelines, and other quality documentation for software maintenance, development and updates, ensuring traceability and compliance.
• Oversee software testing efforts.
• Lay the groundwork for future audits and ensure readiness by establishing clear documentation practices and staying current with relevant regulations and certifications.

Qualifications:

• Education: A suitable degree. Suitable certifications are a plus.
• Experience: Experience in regulatory / quality work in a biotech / life sciences setting and quality management for software products. Basic understanding of bioinformatics a strong plus.
• Skills:
   
  • Expertise in quality management and testing methodologies.
   
  • Expertise in pharmaceutical and medical device regulation.
   
  • Expertise in CE certification process.
   
  • Knowledge of regulatory requirements and industry standards in bioinformatics and healthcare software (e.g., GxP).
   
  • Strong analytical skills with attention to detail.
   
  • Excellent documentation skills and a systematic approach to process design and implementation.
   
  • Skills in bioinformatics a strong plus.

Up for the challenge?

‍
· Please send your CV and motivation letter to careers@precisionphage.com with a title “Quality Manager / [Your name]”
· In the motivation letter, include the timing you would be able to start.
· Send application by January 31, 2025.
· We appreciate every application. Should we proceed with your application,we will get back to you.

‍