Quality Manager Opportunity at Precision Phage
PrecisionPhage, a biotechnology startup in Finland, is seeking a Quality Manager to support the company’s growing quality and regulatory framework across both software and laboratory operations. This role is ideal for professionals experienced in regulated biotech environments, pharmaceutical quality systems, and software validation.
The company is developing innovative bacteriophage technologies, cutting-edge tools, and services that combine advanced software products with laboratory services to support phage producers operating under pharmaceutical regulations. PrecisionPhage is currently working toward ISO 9001 and ISO 27001 certifications while maintaining strong compliance with GxP standards. The GxP-level phage genome integrity and monitoring platform is designed for phage producers working within pharmaceutical regulatory frameworks.
Key Responsibilities
- Quality Management System: Maintain the company’s electronic Quality Management System (eQMS), including document control, change control, training management, and CAPA processes, and ensure ongoing compliance with regulatory standards.
- Certification and Compliance: Lead the development and maintenance of the company’s management systems by driving certification projects for ISO 9001 and ISO 27001.
- Customer Quality and Audits: Act as the primary contact for customer quality enquiries and supporting customer audits, and manage quality agreements with pharmaceutical partners.
- Software Quality and Validation: Maintain validated status of QMS-related software systems and oversee computerized system validation activities.
- Ensure compliance with GAMP 5 guidelines.
Qualifications & Skills Required
- Proven experience establishing and maintaining Quality Management Systems in regulated environments such as pharma, biotech, or medical devices.
- Strong understanding of GxP requirements for software and computerized systems.
- Experience with standards such as ISO 9001, ISO 27001, or SOC 2.
- Ability to manage customer audits and communicate with pharmaceutical quality teams
- Familiarity with development workflows (Agile, CI/CD).
- Experience with GAMP 5 2nd edition, particularly in SaaS environments.
- Experience with eQMS platforms such as SciLife.
- Background in laboratory quality management.
- Experience building new quality processes in startup environments.
How to Apply
Interested candidates can apply through the company’s official application form. Applications will be reviewed on a rolling basis until the position is filled.
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This job post was originally curated by www.thephage.xyz/jobs
