Director of Regulatory and Quality Affairs

Nitta Gelatin a multi-site manufacturing company is seeking a Director of Regulatory and Quality Affairs to join our Toronto, Canada team. This position is responsible for defining and promoting a quality mindset across the entire company. This includes responsibility for managing all QA functions, working with cross-departmental leadership to deliver high quality products on schedule. From hiring analysts and managers to leading incident investigations. Establish and maintain a quality system to ensure a company’s facilities, equipment, personnel, methods, processes, and procedures conform to both internal guidelines and regulatory standards.

TRAINING AND SPECIALIZED KNOWLEDGE REQUIRED

• 5-10 years of relevant food and pharmaceutical quality management & regulatory experience
• In-depth Knowledge of GMP and HACCP requirements
• Experience with Regulatory inspections and inspection readiness
• Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training and CAPA programs)
• Strong team player with demonstrated track record of success in a cross-functional team and fast moving environment
• Excellent organizational, computing and oral/written communication skills
• Ability to influence and negotiate effective solutions
• Strong critical thinking and decision making skills

EXPERIENCE REQUIRED

• Five to 10 years’ experience as QA director and/or QA Manager
• Experience with QA measuring and testing equipment
• Knowledge of safety requirements and legal standards
• Working knowledge of quality system requirements
• Experience with MS Word, Excel, Project Management and Analytics Software

TRAVEL REQUIRED

Up to 30%