Quality Assurance Manager – 12-month Contractor

• Participate in designing, implementing, maintaining, and improving the quality system
• Independently initiate and review SOP updates and create new SOPs
• Oversee review of SOPs and associated documentation to ensure periodic review requirements are met
• Provide hands-on quality expertise to colleagues and partners to support quality and business needs
• Participate in the GxP vendor management program, vendor oversight, QTA generation, and auditing, including serving as lead auditor
• Evaluate partner/vendor Quality Management Systems, resources, premises, and equipment
• Ensure compliance with the latest regulatory and pharmaceutical regulations and trends related to GMP and GDP
• Ensure and participate in scheduled self-inspections of GMP/GDP operations and planned CAPA closure
• Participate in Management Review to assess QMS effectiveness and implement continuous improvements
• Ensure change controls, deviations, complaints, and CAPAs are recorded, reviewed, and completed using risk-based principles
• Participate in regulatory inspections and supplier audits
• Participate in recall and mock recall operations
• Carry out other duties reasonably required and assigned by the manager
• Support the South Cluster, including Serbia, Croatia, Slovenia, Bosnia, Montenegro, and Hungary, with potential extension to other territories
• Support several territories as a member of the EPM QA team and report to the Quality Assurance Associate Director, EPM

• Degree in science or equivalent (pharmacist is the preferred option)
• At least 3 years’ experience in an active QA role in health care sector
• Strong knowledge of regulatory, GDP and GMP requirements
• Excellent written and verbal communication skills
• Experience as quality auditor
• Experience in regulatory inspections is desirable
• Quality function representative on various projects
• Root cause analysis and investigation skills
• SOPs and other quality documents creation
• Strength in critical thinking, problem solving, and decision making
• Collaborative nature, self-directed and independent
• Very strong organizational abilities
• Fluent English

• 12-month contractor role
• Remote/hybrid work arrangement