Senior Director, Quality Assurance - Biologics CDMO (f/m/d) (Duchnice)

Rezon Bio is looking for an experienced Senior Director, Quality Assurance to lead the Quality Assurance function at our Duchnice manufacturing site.
In this role, you will be responsible for ensuring compliance of manufacturing, testing, storage, and distribution activities with GMP regulations, regulatory requirements, and company quality standards. You will provide strategic leadership for Quality Systems, Compliance, and QA Operations while serving as the key Quality representative during regulatory inspections and audits.

Key Responsibilities

• Lead all site Quality Assurance activities, including Quality Systems, Compliance, QA Operations, and Quality Oversight.
• Ensure compliance with EU GMP, FDA, and global regulatory requirements.
• Maintain and continuously improve the site's Quality Management System (QMS).
• Oversee QA review and approval processes related to manufacturing and testing activities.
• Lead inspection readiness and represent the site during Health Authority inspections and customer audits.
• Drive quality culture, continuous improvement, deviation management, CAPAs, and quality risk management.
• Support technology transfers, validation programs, and commercial manufacturing activities.
• Provide leadership, coaching, and development for the QA organization.
• Collaborate with site leadership to ensure compliant and efficient operations.

What We're Looking For

Qualifications

• Master's or PhD degree in Pharmacy, Biotechnology, Biochemistry, Chemistry, Engineering, or a related discipline.
• Minimum 15 years of experience in Quality Assurance and/or Quality Management within the pharmaceutical or biotechnology industry.
• Minimum 5 years of experience in biologics manufacturing, sterile drug products, and aseptic processing.
• Proven experience managing quality systems, regulatory compliance, and site quality organizations.
• Proven success leading FDA, EMA, and other global regulatory inspections.
• Experience working within CDMO/CMO organizations.

Competencies

• Strong knowledge of GMP/GxP requirements and global regulatory expectations (FDA/EMA).
• Understanding of biologics manufacturing, technology transfer, validation, and quality risk management.
• Strategic leadership and decision-making skills.
• Strong organizational and project management capabilities.
• Excellent communication and stakeholder management skills.
• Full professional proficiency in English.
• Eligibility to act as a Qualified Person (QP) under Polish regulations is an advantage.

What We Offer

• A critical leadership role in a growing biotechnology organization, shaping the site quality and compliance strategy.
• The opportunity to ensure the highest standards of compliance, regulatory excellence, and product quality.
• Collaboration with international clients, business partners, and regulatory authorities.
• A direct impact on organizational growth, quality excellence, and inspection readiness.
• The opportunity to lead and develop a high-performing Quality Assurance organization.
• A dynamic, innovative, and science-driven environment with global reach.
• Competitive compensation package with relocation package and attractive benefits:
  • Private medical care.
  • Life insurance.
  • Employee Pension Program (PPE) and Employee Retirement Support (PWE).
  • One additional paid day off per year.
  • Flex Benefits budget (choose from options like MultiSport or Pluxee lunch card).
  • Financial support for skill development.
  • On-site cafeteria serving fresh breakfasts and lunches, with live cooking once a week.
  • Weekly fruit and vegetable days.
  • Access to psychological support.
     

At Rezon Bio, we believe in diversity and equality. Our recruitment process is conducted in a fully transparent manner and with respect for non-discrimination principles – regardless of gender, age, orientation, gender identity, or other individual characteristics. We encourage all individuals who meet the requirements to apply, including women, men, and non-binary persons. What matters most to us is your experience, skills, and passion for achieving goals together!