Head of Quality Assurance Operations

7 dni temu

Warsaw Metropolitan Area, Polska Rezon Bio Pełny etat 90 000 zł - 120 000 zł rocznie

We are seeking a strategic and experienced leader to oversee Quality Assurance Operations at our cutting-edge GMP manufacturing site in Duchnice, Warsaw (Poland). This role is crucial in ensuring the integrity, compliance, and continuous improvement of our Quality Management System (QMS), including associated electronic platforms.

Key responsibilities:

  • Lead and manage the Quality Operations team at Duchnice, Warsaw site.
  • Ensure staffing, qualifications, and budget compliance.
  • Drive Quality System improvements and Inspection Readiness (EMA/FDA).
  • Oversee deviations, CAPAs, escalations, risk management, PQRs, and material release.
  • Provide quality oversight across production, QC, warehouse, and engineering.
  • Ensure data integrity and approve documentation.
  • Support product transfers and launches; work in systems like TrackWise, SAP, LIMS.
  • Monitor KPIs and foster a strong Quality Culture.
  • Participate in audits and inspections; perform other assigned duties.
  • Taking overall responsibility for the costs and QA budget as specified.
  • Providing representation on audits and inspections.

Qualifications & experience:

  • Masters degree in biology, chemistry, pharmacy, biotechnology, or related field.
  • 10+ years in the pharmaceutical or biotech industry, including 2+ years in QA or QC product evaluation.
  • Great knowledge of GMP, ICH guidelines, and Quality Management Systems.
  • Hands on experience in preparation and management of inspections (including FDA).
  • Very good command of English language (both written and spoken).
  • Strong decision-making, problem-solving, and communication skills
  • Excellent
    leadership skills and proven experience leading teams and managing complex tasks.
  • Organized, proactive, and able to work under pressure.

What we offer:

  • A strategic leadership role in a dynamic and growing organization.
  • Opportunity to shape and influence quality standards in a key manufacturing site of the group.
  • Collaborative and innovation-driven work environment.
  • Competitive salary and performance-based bonuses.
  • Comprehensive benefits package- including relocation package.
  • Support for professional development and continuous learning.
  • A mission-driven culture focused on improving patient outcomes through cutting-edge science.

Please note, that position is located in
Poland
, and it does require opennes to relocate.

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