Senior Quality Auditor at Aflac responsible for auditing processes and ensuring quality in service delivery for insurance products.
About the role
- Quality Auditor & Regulatory Compliance Specialist ensuring compliance of plasma suppliers globally at Octapharma. Managing audits, analyzing data, and collaborating with stakeholders.
Responsibilities
- Ensure quality and regulatory compliance of plasma suppliers at a global level
- Manage change control, deviations, and quality-related contracts
- Conduct external supplier audits and participate in customer and internal audits at our facility
- Analyze and trend supplier-related quality data
- Create, review, and provide training on SOPs and related procedures
- Qualify plasma suppliers and service providers (e.g., testing laboratories, logistics partners)
- Monitor and ensure continuous supplier compliance throughout the lifecycle of supply agreements
- Maintain and annually update plasma supplier data
- Perform data entry and second-level checks in a regulatory database
- Ensure compliance with EU and EMA Plasma Master File (PMF) requirements
- Prepare regulatory documentation for annual PMF submissions; evaluate epidemiological data, trends, and risks
- Prepare regulatory responses for marketing authorizations and PMF approvals
- Collaborate with internal and external stakeholders, including suppliers, health authorities, and cross-functional teams
Requirements
- Degree in Life Sciences (e.g., Biology, Chemistry, or Pharmaceutical Sciences)
- Professional experience in Quality Assurance within the pharmaceutical industry
- Proficient knowledge of GMP, EU and FDA guidelines
- Experience with quality management systems, particularly Veeva
- Auditor certification and audit experience; completion of a basic quality auditor or ISO course is a strong advantage
- Structured, reliable, and independent working style, combined with strong communication skills
- Ability to manage priorities, meet deadlines, and demonstrate excellent organizational skills
- Fluency in English and German is required
- Willingness to travel internationally (up to 40%)
- Valid driver’s license
Benefits
- Company restaurant & meal subsidy
- Training and further education
- Health promotion and wellness programs
- Parking spaces and good public transport connections
- Company and team events
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