Director, Quality Assurance

Position Overview:  We are seeking an experienced Director of Quality Assurance to join our team. In this role, you will be accountable for the implementation and improvement of quality management systems to ensure continued compliance with regulatory requirements and industry standards. 

Key Responsibilities:

• Provide strategic direction for quality assurance activities on the production floor in partnership with Manufacturing Operations.
• Establish a strong on-the-floor quality presence, actively engaging with production teams to address immediate quality concerns.
• Provide guidance and support to ensure adherence to quality standards and compliance with regulatory requirements.
• Conduct regular audits and inspections to ensure continuous process optimization.
• Oversee the development, implementation, and maintenance of robust quality systems on the production floor.
• Drive initiatives to streamline quality processes, enhance efficiency, and reduce operational risks.
• Assure delivery of training programs for production staff to enhance their understanding of quality standards and compliance requirements.
• Regulatory compliance and data analysis/reporting
• Prepare comprehensive reports for senior management

Qualifications:

• Bachelor's or advanced degree in a relevant scientific field.
• 8-10 years of experience in quality assurance within the biotech or pharmaceutical industry.
• Experience in quality support in a manufacturing setting.
• Strong knowledge of regulatory requirements and quality standards (e.g., FDA, EMA, TGA).
• Demonstrated success in implementing effective quality systems.