Specialist III, Quality Assurance (Quality Systems)
Gilead Sciences
Gilead Sciences seeks an experienced Quality Assurance specialist to oversee quality management systems, regulatory compliance, and continuous improvement at its Alberta facility. This role provides independent expertise in inspection readiness, deviation management, training systems, and documentation while partnering with cross-functional teams to strengthen quality processes.
Responsibilities
- Provide independent oversight and subject-matter expertise for Quality Management System processes and performance assessment
- Lead quality system improvement initiatives and maintain sustained state of inspection readiness across the site
- Develop, analyze, and report quality metrics and key performance indicators with trend analysis
- Author, review, and maintain controlled quality documents including SOPs, work instructions, and standards
- Oversee site training programs, compliance monitoring, and training effectiveness activities
Requirements
- Bachelor's degree in Science or related discipline with 5+ years relevant experience, or Master's degree with 3+ years
- Experience in Quality Assurance, Quality Systems, pharmaceutical manufacturing, or regulated environments
- Strong technical writing, analytical, and problem-solving skills
- Proficiency interpreting and applying GMP requirements and Quality System procedures
- Experience leading or contributing to cross-functional quality improvement initiatives
- Knowledge of deviation, CAPA, and change control system management
Vacancy posted 5 days ago
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