Director of Quality Assurance
hace 4 días
About the Role
We are seeking a highly experienced Director of Quality Assurance to join our team at Advanced Accelerator Applications (Italy) - S.p.A. in a key role that will oversee the implementation of quality standards, processes, and tools for our external service providers.
Key Responsibilities
- Provide quality assurance expertise and guidance to ensure compliance with quality system requirements, including the implementation of quality risk-based and GxP-relevant processes.
- Review and approve external service provider qualifications and ensure adequate Quality Assurance Agreements (QAA) are in place.
- Lead quality oversight and collaborate with business partners and other quality groups to meet health authority and regulatory requirements.
- Translate functional quality strategy into operational activities and support risk-based implementation.
- Review and approve external service provider Quality Risk Assessments (QRAs) to identify and evaluate risks, trends, and potential quality issues proactively.
- Address quality and compliance gaps, implement strategic process improvements, and monitor the Quality Plan.
- Support inspection readiness activities and assist the Audit team with audit planning and completion of audit CAPA.
- Support clinical trial teams in managing external service providers and IT systems for research and development activities, ensuring corrective and preventive measures for findings are developed and implemented.
- Collaborate with business partners and Procurement for risk evaluation and timely communication of required actions.
- Review quality metrics and ensure follow-up with line functions.
- Contribute to lessons learned from audits, inspections, and incidents, fostering a proactive, risk-based culture.
Requirements
- 12+ years of experience in pharmaceutical development with excellent knowledge of quality management systems and vendor management.
- Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related discipline required.
- Good knowledge of GCP/GLP, GMP, GVP.
- Leadership in implementing robust processes and quality systems in a regulated area.
- Experience managing External Service Providers and knowledge of quality standards and regulatory requirements.
- Technical understanding of quality systems and clinical trial processes.
- Experience in data analysis and trending.
- Effective management of international and cross-divisional collaborations.
- Root cause analysis skills and stakeholder engagement.
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