Quality Systems Improvement Specialist

WHAT WE ARE LOOKING FOR

The Quality Systems Improvement Specialist will be operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

This role focuses on strengthening and improving the Quality Management System (QMS) by translating regulatory requirements, internal assessments, and operational insights into practical, sustainable enhancements. Working cross-functionally with Quality, Operations, and other stakeholders, the Specialist ensures quality systems are robust, compliant, and effectively embedded across the organization. It is a hands-on position dedicated to implementing improvements and driving long-term quality system effectiveness rather than providing oversight alone.

c.YOUR RO

• LELead and actively contribute to the implementation of CAPAs and quality system improvements originating from internal assessments and evaluatio
• nsTranslate regulatory expectations and quality commitments into clear, practical actions across the organizati
• onWork with cross-functional teams to ensure corrective and preventive actions are fully implemented and embedded into routine processes and governance structur
• esMonitor progress of improvement initiatives, identify barriers, and facilitate resolution with relevant stakeholde
• rsVerify effectiveness of implemented actions through structured follow-up, data analysis, and objective eviden
• ceContribute to the continuous improvement and integration of core QMS elements, including change control, deviations, CAPA management, internal audits, and document management syste
• msCollaborate with stakeholders to ensure QMS processes remain robust, practical, and aligned with regulatory expectations and company polici
• esSupport the development and maintenance of governance structures that enable accountability, effective decision-making, and sustainable complian
• cePerforms other duties as assigned by manageme

ntYOUR BACKGROU

NDRequired Qualificatio

• nsBachelor’s degree in Life Sciences, Quality, Engineering, or a related field (or equivalent combination of education and experienc
• e)10+ years of experience in pharmaceutical Quality Assurance, Quality Systems, or Quality Compliance within a GMP-regulated environme
• ntDemonstrated experience contributing to Quality Management System (QMS) improvements or transformation initiativ
• esStrong expertise in root cause analysis, CAPA systems, and quality governance framewor
• ksSolid understanding of 21 CFR Parts 210 and 211 and general GMP regulatory expectatio
• nsPractical experience applying Quality Risk Management (ICH Q9) principles and risk-based decision-maki

ngPreferred Qualificatio

• nsExperience working in sterile manufacturing or terminal sterilization environmen
• tsKnowledge of global regulatory expectations for sterile products (e.g., FDA, EMA, PIC/
• S)Experience supporting regulatory inspections, audit readiness, or quality system remediation effor