Quality Manager – Quality Assurance

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

📋 Description

• Cultivate a quality-centric culture across the organization while serving as an advocate for the QA department.

• Prepare, uphold, and execute both internal and vendor Strategic and Annual Audit Programs.

• Spearhead the design, execution, and management of audits for both internal processes and vendors.

• Oversee associated quality risk management initiatives.

• Establish and maintain a robust internal Quality Risk Assessment methodology.

• Create and sustain a comprehensive Audit Universe.

• Direct Quality Assurance efforts concerning procurement and vendor supervision.

• Develop, uphold, and manage systems for continuous monitoring and compliance with relevant laws and regulations, including EU GVP, USFDA CFRs, JMPA, and ICH-E6 standards.

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

• Organize and contribute to internal system and vendor audits as per the Company Audit Plan.

• Oversee pre-audit and post-audit processes.

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

• Plan, coordinate, or perform Quality as a Service audits.

• Provide GxP QA consultancy in accordance with expertise and experience.

• Monitor organizational adherence and evaluate its influence on audit strategy, plans, and execution.

⛳️ Requirements

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

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

• Minimum of 3 years of direct auditing experience in GCP and/or GVP domains.

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

• Strong organizational skills and meticulous attention to detail.

• Excellent communication and facilitation abilities within a global organization.

• A proactive mindset.

• Proficient in English.

🏝️ Benefits

• Option for remote work.

• Emphasis on work-life balance.

• Collaborative and international team atmosphere.

• Opportunities for career advancement.

• Empowered ownership and early impact.

• Cooperative partnerships.

• Supportive workplace culture.

• Chance to contribute to significant work that aids in delivering safe and effective pharmaceutical treatments to patients.