This is a fully remote position, open to applicants in Bosnia and Herzegovina.

📋 Description

• Promote a culture of excellence within the Company and serve as an advocate for the QA department.

• Develop, manage, and execute both internal and vendor-focused Strategic and Annual Audit Programs.

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

• Direct related quality risk management initiatives.

• Create and sustain the internal Quality Risk Assessment framework.

• Establish and maintain a thorough Audit Universe.

• Supervise Quality Assurance efforts associated with procurement and vendor management.

• Create and oversee systems for continuous monitoring and adherence to 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 auditing strategy.

• Organize and participate in internal system and vendor audits, encompassing pre-audit and post-audit tasks.

• Perform audits or manage the peer review process for audit documentation and quality control activities within GxP expertise.

• Plan, coordinate, or carry out Quality as a Service audits and offer GxP QA consulting.

• Monitor organizational compliance and evaluate its effect on audit strategy, planning, and execution.

⛳️ Requirements

• Bachelor's or Master's degree in biomedical sciences, natural sciences, health sciences, or a related scientific field, or a comparable mix of advanced education and relevant industry experience.

• Familiarity with GVP and GCP regulatory requirements, or a willingness to expand knowledge.

• 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.

• Exceptional communication and facilitation abilities within a global organization.

• Proactive mindset.

• Proficient in English.