Head of Quality Assurance Operations (Duchnice)
Duchnice, PL
Join Rezon Bio, where biotech experts create biologics that improve lives worldwide - not by following the old rules, but by finding better, more reasonable ways to do things.
Built on the excellence of Polpharma Biologics, Rezon Bio is evolving into a Contract Development and Manufacturing Organization (CDMO) with a clear reason: to challenge the status quo and raise the bar in biotech.
With state-of-the-art centers in Gdańsk and Warsaw-Duchnice, we offer career opportunities across science, technology, and business for those who want their work to truly resonate.
Work alongside 1,300 professionals who combine global ambitions with local roots – driven by science, purpose, innovation, and respect for diversity.
We are seeking a strategic and experienced leader to oversee Quality Assurance Operations at our cutting-edge GMP manufacturing site in Duchnice, Warsaw. This role is pivotal 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 site.
- Ensure staffing, qualifications, and budget compliance.
- Drive Quality System improvements and Inspection Readiness (GIF/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.
- Very good command of English language (both written and spoken).
- Strong decision-making, problem-solving, and communication skills
- Great 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
- Support for professional development and continuous learning.
- A mission-driven culture focused on improving patient outcomes through cutting-edge science.
We fuel your professional growth and back it with a comprehensive benefits package. Our advanced facilities support both commercial-scale production and cutting-edge R&D, making us one of the most modern biotech organizations in Europe.
Here your ideas resonate and drive meaningful change. With continuous learning opportunities, many experts have already found their reason to return or relocate to Poland and grow their careers with us.
Does this resonate with you?
Learn more at RezonBio.com/careers and on LinkedIn