Quality Compliance Specialist II - QMS (f/m/d)

Are you passionate about quality systems, compliance, and continuous improvement in a regulated pharmaceutical environment?
We are looking for a Quality Compliance Specialist to support and maintain our Quality Management System (QMS), ensuring compliance with GMP, GDP, Data Integrity, and other applicable pharmaceutical requirements.

Key Responsibilities

• Support the implementation, monitoring, and maintenance of the Quality Management System (QMS).
• Ensure activities are performed in accordance with GMP, GDP, Data Integrity (DI), and applicable pharmaceutical regulations.
• Facilitate, oversee, and participate in quality events and processes, including Deviations, CAPA / sCAPA management, Effectiveness checks, Change Controls, Extensions and Escalations.
• Collaborate with cross-functional teams to ensure timely completion and closure of QMS documentation.
• Participate in the implementation and enhancement of QMS-related applications and systems.
• Prepare, review, and maintain quality documentation in compliance with regulatory requirements, GMP standards, and Quality Agreements (QAA).
• Collect and analyze data for Quality KPIs and prepare associated reports.
• Present QMS metrics, trends, and compliance data during management review and quality meetings.
• Develop, review, and update Standard Operating Procedures (SOPs), Work Instructions, and other quality system documentation.
• Prepare quarterly and annual trend analysis reports related to QMS performance.
• Support internal and external audits, inspections, and regulatory assessments.
• Act as a quality representative during audits and inspections, presenting applicable QMS processes and records.

Qualifications & Experience

• Bachelor's or Master's degree in Biology, Chemistry, Pharmacy, Biotechnology, or a related scientific field.
• 5 years of experience in the pharmaceutical / biopharmaceutical industry.
• Strong knowledge of Good Manufacturing Practice (GMP) requirements and pharmaceutical regulations, particularly within the ICH (International Council for Harmonisation) environment.
• Good understanding of Quality Management Systems (QMS) and quality processes within a regulated pharmaceutical setting.
• Experience working with quality documentation, compliance processes, and quality system records is highly desirable.
• Proficient in Microsoft Office applications 
• Good command of English, both written and spoken (main language of communication within the Team is English – please submit your application in English)
• Strong communication and interpersonal skills with the ability to collaborate effectively across cross-functional teams.

What We Offer

• Employment with one of Poland’s leading biotechnology companies.
• An opportunity to work in a highly regulated environment focused on quality, compliance, and continuous improvement.
• Meaningful and engaging challenges with direct impact on the development and enhancement of the Quality Management System (QMS).
• Collaboration with experienced Quality Assurance professionals and cross-functional teams across the organization.
• Competitive salary complemented by annual and special occasion bonuses.
• An attractive benefits package, including:
  • Private medical care.
  • Life insurance.
  • Employee Pension Program (PPE) and Employee Retirement Support Program (PWE).
  • One additional paid day off per year.
  • Flex Benefits budget (e.g., MultiSport card or Pluxee lunch card).
  • Financial support for professional development and further training.
  • Free transportation to the workplace (two dedicated bus lines, from Ożarów Mazowiecki and Warsaw - Bemowo).
  • On-site cafeteria offering fresh breakfasts and lunches, including live cooking sessions once a week.
  • Weekly fruit and vegetable days.
  • Access to professional 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!