Quality Manager

We are looking for a Quality Manager to join PrecisionPhage! We are seeking an expert in bridging pharmaceutical quality expectations with modern software development practices.

We are an academically grounded biotech startup working on phage technologies, using both software products and laboratory services. Our spearhead product is a GxP-level phage genome integrity and monitoring tool used by phage producers operating under pharmaceutical regulations. We also operate a phage laboratory, and quality work spans both software and laboratory operations (with main focus on software). We are pursuing ISO 9001 and ISO 27001 certifications.

The 9001 certification project is well under way. We have a validated eQMS software in use, established software life-cycle management processes, and a development team that already works within GAMP 5 and understands change control. You would report to the company lead and work closely with the development team. This is a hands-on role with significant autonomy.

Our working language is English and our market is worldwide. This position is for applicants able to work remotely or hybrid within the standard office hours of European time zones. The job posting remains open until a suitable candidate is found.

Please apply using this form

Key responsibilities

• Owning and maintaining our eQMS (SciLife) including e.g. document control, change control, trainings, and CAPA management.
• Establishing Management System together with the management team, driving ISO 9001 and ISO 27001 certification and maintaining compliance post-certification.
• Acting as the primary quality contact for customer quality enquiries, audits and quality agreements.
• Maintaining the validated status of QMS owned software, overseeing computerized system validation activities and ensuring GAMP 5 compliance in collaboration with the development team.
• Staying current with relevant GxP and information security regulations and assessing their impact on our products and processes.
• Working directly with the development team to integrate quality into existing workflows.
• Driving sustainability related actions

Necessary qualifications

• Demonstrated experience in establishing and maintaining quality management system in a regulated environment (pharma, biotech, medical devices, or similar) and/or in software quality management.
• Practical understanding of GxP requirements and how they apply to software / computerized systems.
• Experience with ISO 9001, ISO 27001, SOC2 or similar standards.
• Ability to handle customer audits and communicate confidently with pharma quality teams.
• Excellent English communication skills, both written and oral.

These qualifications are seen as a plus

• You're comfortable working alongside software developers and understand modern development workflows (e.g. Agile vs waterfall and how they impact quality).
• Experience with GAMP 5 2nd edition, especially in a SaaS context.
• Familiarity with eQMS platforms (SciLife, or similar).
• Experience working in an environment where you build processes rather than maintain inherited ones.
• Experience with laboratory quality management.

Why join us?

We are an academically founded phage biotech startup in Finland, building software and services that support the clinical use of bacteriophages. Our company is growing fast and establishing a central role in the global phage field. We have a strong team culture and embrace continuous learning and improvement. Some perks:

• Opportunity to shape quality in a company where it's genuinely integrated into the product.
• Flexible working hours, with possibility for 100% remote work or hybrid work in our offices in Jyvaskyla or Turku, Finland.
• Work in a lean startup environment without the rigidity of corporate bureaucracy (while acknowledging the posture required for GxP-level software development).
• Make a real impact on healthcare and research through your work.
• Modern tooling: eQMS, compliance automation, CI/CD, infrastructure as code.
• Support for professional development, training, and certifications.

Please apply using this form

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