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QA Manager
2 weeks ago
The Quality Assurance Manager is responsible for defined aspects of the day-to-day operational activities of the Quality Assurance function in the Company. This role will demonstrate capabilities across the entire spectrum of quality systems internally and external to the company (with internal stakeholders, contract service providers, customers,..). The GxP Quality Assurance Manager position will implement, troubleshoot, and continuously improved processes, conduct/approve deviations, investigations, non-conformances, corrective and preventive actions (CAPA), change controls. Coordination, conduction and management of the full process of audits (internal and external) is a key responsibility of the role.
Lead risk management initiatives including risk assessment of key processes and changes and track and trend of data. Provide training for functional teams, support, and escalate compliance issues to senior management in a timely manner. This is a highly visible role with responsibility and cross functional influence that has an impact on organization performance and broad quality initiatives requiring primarily tactical decision making.
The role encompasses also responsibility of the company Regulatory Affairs management, with direct responsibility of preparation, submission and maintenance of company multiple certifications, authorizations and accreditations, interacting on behalf of the company with multiple bodies, including institutional entities.
Participate proactively in European QA integration initiative and related activities, contributing to the development of improved practices and policies in this broader scope.
**Qualifications**:
- Minimum of 5 years pharmaceutical or biotechnology industry GMP experience in quality
- In-depth knowledge of GMPs (EU, US). Knowledge of pf GLP and ISO quality systems is a clear plus for the role
- Experience in working with external partners and/or customers
- In-depth knowledge of Quality principles, concepts, industry practices and standards
- Ability to work independently with scientific/technical personnel
- Knowledge of risk management tools a plus
- Demonstrated leadership skills in the areas of driving results, team collaboration, team building, problem solving, and communication across functional areas
- Excellent written, oral and interpersonal communication skills, in Italian and English language
- Demonstrated ability to work independently and practically, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
**Education Required**: Bachelor of Science degree, in a related scientific discipline
**Computer Skills**: Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
