Directs and leads the Canadian business and utilizes our Practical Process Improvement (PPI) system to ensure a continued and sustainable culture of quality and compliance. Acts as the key point of contact for customer audits, external audits, and government inspections. Leads a team of Quality and Regulatory personnel to ensure continued compliance of our Canadian operations. Manages quality systems (ISO 9001, ISO 13485, and ISO 17025). Maintains regulatory framework programs to ensure compliance to all applicable regulations. Ensures timely periodic reviews and updates to the document management system. Coordinates with Global Quality and Regulatory colleagues and adopts best practices. Leads harmonization of processes globally where possible. Directly reports to Sr. Global Quality Leader.
Responsible for liaising between Thermo Fisher Scientific and government agencies, suppliers, customers, as well as other companies and organizations in the scientific community in order to ensure compliance with all applicable regulations and the projection of a positive image within the scientific community. Develops, updates and oversees internal audits of all sites.
- Ensures Thermo Fisher Scientific’s Quality System complies with the appropriate ISO Standard.
- Supports all functional divisions within Canada to ensure integrity of the quality systems and compliance to all applicable regulations.
- Coordinates with Portfolio Management for new and existing products and to resolve supplier issues including product complaints.
- Liaises with legal as needed to address compliance matters.
- Develops, updates and supports internal quality audits of all Canadian sites.
- Ensures that all current, and any new items which we offer for sale, comply with the regulations as defined by the Health Protection Branch - Bureau of Pharmacy, Medical Device and other applicable government regulations.
- Coordinates all product recalls and retrofits.
- Ensures our packaging and shipping practices comply with the Transport of Dangerous Goods regulations.
- Ensures that our packaging practices comply with WHMIS 2015 (Workplace Hazardous Material Information System) and that Safety Data Sheets (SDS’s) are available for all hazardous products.
- Ensures compliance with regulations with regard to radioactive products, spills, and any other government regulations that affect our products.
- Acts as a delegate to appropriate committees of various professional organizations in order to contribute to, and keep abreast of, current developments of a regulatory nature.
- Develops and maintains written guidelines and/or manuals for each area of responsibility.
- Responds in a timely manner to all correspondence from Business Partners and global quality personnel.
- Bachelor of Science Degree in Chemistry, Bio-Chemistry, Biology, Engineering, or Applied Sciences. Masters of Science or Advanced Degree preferred.
- Five to ten years’ experience in a responsible position in representative fields such as medical device manufacturing, healthcare, pharmaceutical, chemicals, educational or hospital environments.
- Excellent communication skills (verbal or written), good negotiation ability to use tact and diplomacy.
- Good organizational skills.
- Good ability to author process documents.
- Good lead auditor skills.
- Good supplier management, CAPA, complaint handling, supply chain knowledge.
- Manufacturing, Distribution, and Supply Chain experience a plus.