Group Head Compliance (Gdańsk / 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.
The Group Head of Compliance leads and supports compliance activities across both Rezon Bio’s sites (Gdańsk and Duchnice) in cooperation with VP Group Compliance and Duchnice Site Quality Assurance. This role ensures alignment with regulatory requirements, internal standards, and industry best practices. It is responsible for deploying and managing the compliance framework, overseeing quality systems, and driving continuous improvement across the organization.
Key responsibilities:
- Lead Compliance Governance: Lead the execution of Rezon Bio’s quality and compliance governance framework across both sites. Analyze QA reports, identify trends, and drive corrective actions. Monitor initiative effectiveness and escalate critical issues.
- Audit & Inspection Readiness Across Sites: Coordinate and support regulatory inspections (for example EMEA, FDA) and customer audits. Ensure operational readiness, manage documentation, and lead CAPA development. Plan and execute internal Group audits.
- Site Oversight & Monitoring: Conduct internal compliance assessments at Rezon Bio. Collaborate with site QA teams on improvement plans. Manage escalation and investigation of major compliance issues.
- Risk & Issue Management: Act as a key support and liaison for quality and compliance risk escalations from site teams or customers. Lead and oversee initial investigation and resolution efforts, and escalate high-risk or systemic issues.
- Customer & Stakeholder Engagement: Serve as the ultimate compliance contact for customer audits and queries. Ensure a consistent compliance experience across functions and geographies.
- Regulatory Intelligence & Improvement: Track regulatory changes and industry trends. Support global compliance strategy rollout and promote continuous improvement through metrics, training, and stakeholder engagement.
- Cross-Site Alignment: Drive alignment of compliance activities and ensure timely communication of expectations and initiatives across all Rezon Bio locations.
Qualifications & experience:
- Master’s or PhD in biology, pharmacy, biotechnology, chemistry, chemical engineering, medicine, or related.
- Minimum 15 years in pharmaceutical / biotech manufacturing, including 2 years in quality control or assurance.
- Deep knowledge of GMP and pharmaceutical regulations.
- Proven experience with FDA and EMA inspections.
- Strong auditing and quality systems management background.
- Excellent leadership, decision-making, and project management skills.
- Strategic thinker with resilience under pressure.
- Very good working knowledge of English language.
- Confident in representing the company externally.
What we offer:
- A strategic leadership role in a dynamic and growing organization.
- Opportunity to shape and influence compliance standards across the whole organization.
- 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