Duncan Li Email & Phone Number

Mississauga, On, Ca

Markham, Ontario, Canada

- Design, implement, maintain and continuously improve J&J MedTech's Quality System to support the business and comply with Health Canada, FDA and J&J requirements- Lead collaboration efforts with cross-sector (Pharma, Consumer and Vision) and global counterparts (EMEA, LATAM, APAC) to support Quality Systems simplification and harmonization efforts- Build and maintain strong relationships with internal/external stakeholders including regulatory agencies, source companies, cross-sector/global counterparts and commercial partners- Lead and foster talent development, and empower direct reports to execute with speed, transparency and accountability to ensure appropriate Quality KPI/Metrics are met and annual Goals & Objectives are achieved - Oversee Purchasing Control requirements for suppliers, distributors and facilitate supplier selection, audits, on-going performance monitoring process- Oversee Quality Issue-related Programs (Escalation, CAPA, Non-Conformances, Risk/Impact Assessments) and monitor compliance - Oversee Document Control, Training, Change Control programs and monitor overall compliance - Oversee the execution of Hold/Stop Shipments, Field Actions/Recalls impacting J&J MedTech products to ensure timely actions are taken to rectify the situation- Host External Audits (Health Canada) and assist during Franchises' Health Authority Audits (FDA)/Notifying Body Inspections (BSI, MDSAP)- Implement and maintain Quality Agreements with Partner Companies (ICQAs), Suppliers and Distributors- Provide compliance expertise to support new product launches, Go-to-Market models, Repack-Relabel initiatives- Support Drug Compliance and adherence to Good Manufacturing Practices for J&J MedTech's rug/biologic product portfolio- Manage J&J MedTech's internal audit program- Prepare and present quality compliance information at Quality System Management Reviews to leadership team

Markham, Ontario, Canada

- Lead and develop Complaint Handling Unit team members to ensure the complaint management process is effective and continuously maintained and improved- Responsible for team’s overall goals & strategy direction, coordination, development and evaluation- Develop weekly/monthly goals and schedules to manage activities and team’s workload as required- Design, implement, maintain and continuously improve J&J MedTech Canada's Complaint systems to support business and comply with Health Canada and J&J requirements- Regional representative in Global governance and strategy meetings to shape the end to end complaint management process - Partner closely with Commercial and Analytics team to create reports that measure key compliance metrics and are customer centric providing insights to the business- Review changes to regulations and guidance documents and provide industry feedback during consultation period - Collaborates with various functions (Franchise Subject Matter Experts (SMEs), Sales, Marketing, Supply Chain and Logistics) to develop a strategy to address customer and regulators safety queries and concerns. Prepares and facilitates responses- Hosts and leads Internal and External Audits as it pertains to complaints; ability to communicate regulatory and process as a SME during regulatory and internal inspections- Representing Canada on company-wide complaint handling initiatives and in Quality Management Reviews- Overseeing, drafting Mandatory Problem Reports (MPRs) to comply with Health Canada regulations

Markham, On.

- Execute holds/stop shipments to ensure products are investigated, segregated and on ERP system-hold.- Connect with appropriate stakeholders to ensure holds/stop shipments are execute in timely manner.- Follow-ups with Global Manufacturing sites to provide product disposition and closure status.- Initiate/coordinate recall/field actions with the team and be responsible for developing and executing recall strategies.- Conducting key Quality and Regulatory compliance activities associated with recalls including communications with Health Canada, documenting recall strategies, coordinating review and approval of recall communications, coordinating review and approval of recall communications, reconciling customer responses and effectiveness checks, and closure of recall files.

Guelph, On.

- Implementing and maintaining new enterprise systems to the Quality Assurance & Compliance Department.- System Administrator for lab instruments, responsible for troubleshooting and validating lab instruments.- Technical report writing, documentation review and execution of protocols.

Burlington, Ontario

- Researching and developing starch-based nanomaterials as an alternative to existing non-renewable polymer materials.- Characterize in-house and competitor’s products using advanced Analytical and Organic Chemistry techniques.

Etobicoke

- Sample preparation and extraction using analytical chemistry procedures.- Analyzing water and gas samples using HPLC, GC/MS, GC/FID and ICP.- Research and development of new analytical methods for analysis of samples.

Downsview

- Developing methods using PTR-MS to detect Volatile Organic Compounds (VOCs).- Measuring air quality by quantifying VOCs in aerosol samples.- Responsible for data analysis, data processing and report writing.

Mississauga

- Responsible for innovation, development and reformulation of products.- Demonstrated strong sense of independence and responsibility working under tight deadlines.- Analyzing results and weekly reports to the R&D and marketing team.- Conducted pilot plant trials scaled up from lab bench experiments.

Brampton

- Constructed and managed an intramural sports program for students to encourage school spirit and promote healthy living in school.- Strong sense of leadership portrayed and communication skills working with at-risk students to ensure success in their academics.

Master'S Degree, Organic Chemistry

Bachelor'S Degree, Honours Biochemistry