DIRECTOR OF REGULATORY & QUALITY AFFAIRS

Director of Regulatory and Quality Affairs

** This position is located in Toronto, Canada**

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.

Some duties include but not limited to: 

o    Collaborate with NGI Headquarters and group companies to enhance global Quality Management and Regulatory compliance.
o    All products sold by NGC, Vyse, and NGNA fall within the scope of this role.
o    Provide customer-centric QA, QC, and Regulatory support to the customer service and sales groups.
o    Supervises Quality Assurance Managers (NGC and Vyse) and has responsibility for the Quality Team who reports to them.
o    Manages NGC and Vyse Lab Supplies Budget and Capital Budget for new Lab equipment.
o    Designs/Implements/Maintains NGC and Vys lab procedures as required by ISO 9002/2000 and FSSC 22000.
o    Evaluates NGC Pig Skin and Gelatin, and Vyse & NGNA Gelatin/Collagen peptide Supplier quality levels and adherence to GMP’s
o    Evaluates and updates test procedures and resolves quality issues as required by customers or production needs.
o    Evaluates and commissions new lab equipment as required.
o    Interfaces with the Sales group and customers as required to resolve outstanding quality issues or concerns.
o    Lead role in troubleshooting production quality problems.
o    Ensures that timely and appropriate quality reports are generated.
o    Helps establish appropriate process targets to optimize production efficiencies or to improve quality, through project or test work.
o    Effectively work with other NGC, Vyse and NGNA departments and personnel.
o    Directs and controls all quality assurance programs and systems (ISO, GMP, HACCP) at NGC and Vyse.
o    Works with Customers to resolve quality issues and improve quality.
o    Overall responsibility for developing and maintaining SQC systems at NGC and Vyse.
o    Overall responsibility for developing and maintaining SQC training programs for plant personnel.
o    Keeping up-to-date on all regulatory issues affecting gelatin/collagen peptide and implementing plans to ensure NGC, Vyse and NGNA conforms as required.
o    Must follow food safety regulations
o    Other duties as assigned.

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
• TRAVEL REQUIRED Up to 30%

Some of the reasons our selected candidates will want to work with us:

• Insurance benefits such as: · Health, Dental & Vision
• PTO
• Employee Recognition Programs
• RRSP with match.
• 10 Paid Holidays per year
• Annual Bonus (*based on achievement of assigned goals & company performance)
• Company-sponsored engagement events.