Director of Quality

Role – Director of Quality

Location – Paris – 80% remote working

Scienta are teaming up with a leading gene therapy company seeking to apply pathbreaking science to help patients with severe inherited diseases of the eye and central nervous system.

Under the responsibility of the VP Regulatory Affairs & Quality Assurance, the Director of Quality is responsible for:

• Organize and supervise all activities of the Quality department, supervise the department’s employees,

• Implement the quality policy,

• Ensure management of the quality system,

• In coordination with the CEO and department directors, promote and contribute to the development of a quality improvement approach,

• Maintain the company’s organization chart up to date, ensure the development and maintenance of employee job descriptions, ensure employee training with department directors,

• Support, in terms of quality, the departments (manufacturing, distribution, clinical trials, regulatory, vigilance, medical information, communication),

• Define and monitor the company’s Quality indicators, in coordination with the departments concerned,

• In collaboration with the departments concerned, develop an internal and external audit plan and ensure its implementation, ensure the carrying out of audits and follow-up,

• Ensure the management of deviations, complaints, CAPAs, change controls and risk assessments,

• Coordinate Quality reviews, validate action plans proposed as part of the continuous quality improvement process,

• Ensure inspection readiness with the departments, manage regulatory authorities inspection hosting with the departments,

• Ensure the archiving of pharmaceutical and quality documentation.

Knowledges

• GMP

• GCP

• GVP

• ISO 13485, 9001

• European, French, US regulations related to medicines and medical devices