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Director of Quality Management
3 weeks ago
The Associate Director of Quality Assurance is a pivotal leader in Exokeryx's quality strategy. This role ensures seamless integration of quality and compliance into daily operations, aligning with the organization's long-term goals. The position provides strategic direction and oversight for Quality Assurance functions, driving harmonization of quality processes, including risk management, GMP core management, and global regulatory requirements.
Key Responsibilities:- Lead internal audits, client audits, and regulatory inspections to ensure compliance with GMP guidelines.
- Support supplier selection and lead supplier audits to maintain high-quality standards.
- Oversee Quality Management Review meetings and provide strategic guidance on quality-related matters.
- Determine inspection readiness plans and activities to ensure regulatory compliance.
- Prepare product and process quality reports by analyzing trends and information.
- Develop training sessions based on audit and inspection learnings to enhance quality awareness.
Qualifications:
- Bachelor's degree in a scientific discipline or related field.
- Minimum 8 years of experience in compliance, quality, and CMO management within the pharmaceutical or biotechnology industry.
- 5 years of experience in leadership roles, preferably in QA management.
- 10+ years of GMP experience and 10-12 years of QA-related experience.
