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Full-timeWhite Collar
Director Of Quality And Development
HeliopolisQualityOn-site
Job Description
The Director of Quality and Development will oversee the quality assurance and product development processes within our biotechnology and pharmaceuticals division, ensuring compliance with regulatory standards while driving innovation and product effectiveness. This strategic role requires collaboration across departments to enhance product quality and integrate quality by design (QbD) principles throughout the development lifecycle.
Responsibilities
- Lead the Quality Assurance and Development teams to ensure compliance with FDA, EMA, and other regulatory requirements.
- Develop and implement quality strategies and systems to ensure product excellence in all developmental phases.
- Collaborate with R&D, Operations, and Regulatory Affairs to align development initiatives with quality standards and guidelines.
- Conduct regular audits and assessments to ensure adherence to quality protocols and identify areas for improvement.
- Guide and mentor team members on best practices in quality management and product development methodologies.
- Oversee documentation and reporting processes to maintain compliance with industry standards.
- Explore and implement innovative technologies and methods to optimize product development and quality control.
Requirements
- Master's degree in Biotechnology, Pharmaceutical Sciences, or a related field; Ph.D. preferred.
- 10+ years of experience in quality assurance and product development within the biotechnology or pharmaceuticals industry.
- Proven track record of managing teams and leading cross-functional projects.
- Strong knowledge of regulatory requirements and international standards (FDA, ISO, ICH).
- Excellent problem-solving skills and attention to detail.
- Demonstrated ability to influence and guide teams towards quality-focused goals.
- Exceptional communication and leadership skills.