Quality Manager – Quality Assurance

This is a fully remote position, open to applicants in Serbia.

📋 Description

• Cultivate a quality-centric culture within the Company and serve as a representative for the QA department.

• Prepare, sustain, and implement internal and vendor Strategic and Annual Audit Programs.

• Oversee the design, execution, and administration of internal and vendor audits.

• Direct relevant quality risk management initiatives.

• Create and uphold the internal Quality Risk Assessment methodology.

• Develop and maintain a thorough Audit Universe.

• Lead Quality Assurance efforts concerning procurement and vendor oversight.

• Establish, sustain, and oversee systems for continuous monitoring and compliance with relevant laws and regulations, including EU GVP, USFDA CFRs, JMPA, and ICH-E6.

• Collaborate with Vendor Management and operations teams to implement a risk-based and compliant audit strategy.

• Organize and participate in internal system and vendor audits in line with the Company Audit Plan.

• Oversee pre-audit and post-audit processes.

• Conduct audits or coordinate audit documentation peer reviews and quality control activities within GxP expertise.

• Plan, organize, or execute audits and offer GxP QA consultancy for client-contracted Quality as a Service activities.

• Monitor organizational compliance and evaluate its effect on audit strategies, plans, and execution.

⛳️ Requirements

• A Bachelor’s or Master’s degree in biomedical sciences, natural sciences, health sciences, or another pertinent scientific field, or an equivalent combination of advanced education and relevant industry experience.

• Familiarity with both GVP and GCP regulatory standards, or a willingness to expand expertise.

• A minimum of 3 years of direct auditing experience in the GCP and/or GVP domains.

• At least 2 years of experience in audit program management, including the development and upkeep of risk-based audit plans.

• Strong organizational skills and meticulous attention to detail.

• Exceptional communication and facilitation abilities within a global organization.

• A proactive mindset.

• Proficiency in English.

🏝️ Benefits

• Option for remote work.

• Emphasis on work-life balance.

• Collaborative, international team atmosphere.

• Opportunities for career advancement.

• Trusted ownership and independence.

• A passionate and cooperative team of experts in clinical research, pharmacovigilance, and quality consulting.