09 Nov
|
BEIERSDORF
|
Montreal
09 Nov
BEIERSDORF
Montreal
- Lead country quality and compliance activities for products sold in Canada
- Maintain the local QMS and author or approve BDF Canada SOPs, quality reports and controlled records
- Oversee Canadian product release, stability and microbiological testing, deviations, OOS investigations and CAPA
- Maintain Drug Establishment, medical-device and site licenses and support DIN/NHP registrations and launches
- Approve DIN, NHP, cosmetic and medical-device labels; review claims and advertising materials when required
- Lead cross-functional quality activities through coaching, collaboration and technical expertise.
- Support product availability and coordinate with Planning, Purchasing, Customer Service, Finance, Sales, Packaging and Marketing
- Serve as the point person for Canadian quality issues and advise the business on compliance matters
- Assess, communicate, escalation and mitigate quality risks that may impact product quality, consumer safety, regulatory compliance or business continuity while maintaining alignment with cross-functional partners.
- Manage qualification and quality oversight of warehouses, QC consultants, external laboratories, PCs, 3PMs, distribution centres, carriers and VAS providers
- Establish and maintain quality agreements with BDF Canada contractors and service providers
- Audit external partners such as Accuristix, Harling and RD Labs and BDF manufacturing sites including BMP and BMM
- Oversee VAS batch release and documentation, finished-goods release records and complaint investigations
- Develop suppliers through re-audits and troubleshooting; initiate and verify effective CAPA
- Reduce consulting costs by conducting external site audits directly where appropriate
Your Tasks
- Lead country quality and compliance activities for products sold in Canada
- Maintain the local QMS and author or approve BDF Canada SOPs, quality reports and controlled records
- Oversee Canadian product release, stability and microbiological testing, deviations, OOS investigations and CAPA
- Maintain Drug Establishment, medical-device and site licenses and support DIN/NHP registrations and launches
- Approve DIN, NHP, cosmetic and medical-device labels; review claims and advertising materials when required
- Lead cross-functional quality activities through coaching, collaboration and technical expertise.
- Support product availability and coordinate with Planning, Purchasing, Customer Service, Finance, Sales, Packaging and Marketing
- Serve as the point person for Canadian quality issues and advise the business on compliance matters
- Assess, communicate, escalation and mitigate quality risks that may impact product quality, consumer safety, regulatory compliance or business continuity while maintaining alignment with cross-functional partners.
Supplier Management:
- Manage qualification and quality oversight of warehouses, QC consultants, external laboratories, PCs, 3PMs, distribution centres, carriers and VAS providers
- Establish and maintain quality agreements with BDF Canada contractors and service providers
- Audit external partners such as Accuristix, Harling and RD Labs and BDF manufacturing sites including BMP and BMM
- Oversee VAS batch release and documentation, finished-goods release records and complaint investigations
- Develop suppliers through re-audits and troubleshooting; initiate and verify effective CAPA
- Reduce consulting costs by conducting external site audits directly where appropriate
Product Compliance:
- Manage medical-device lifecycle compliance and complaints
- Conduct internal PC audits and support Hamburg with DEKRA medical-device audits
- Maintain MSDS information and ensure regulatory documentation remains current
- Collaborate with R&D; and Hamburg on claims support, compliance and product-launch requirements
Quality Management:
- Own and maintain the effectiveness of the Canadian Quality Management System through KPI monitoring, management review, quality planning, escalation management and continuous improvement activities.
- Lead complaint trending, root-cause investigation, CAPA and PPM-reduction initiatives
- Drive risk-based decision making through trend analysis, complaint monitoring, CAPA effectiveness reviews and management-review activities.
- Conduct internal GMP training and support audit readiness
- Execute and evaluate on-shelf store checks; drive corrective actions and complete monthly reporting
- Manage MCS and Cal Labs Quality budgets for stability testing, microbiological testing and product release
- Ensure local processes align with North America, Global Quality and applicable Canadian requirements
- Maintain continuous readiness for He
📌 Senior Quality Manager (Montreal)
🏢 BEIERSDORF
📍 Montreal