13 Nov
|
BEIERSDORF
|
Canada
Lead country quality and compliance activities for products sold in CanadaMaintain the local QMS and author or approve BDF Canada SOPs, quality reports and controlled recordsOversee Canadian product release, stability and microbiological testing, deviations, OOS investigations and CAPAMaintain Drug Establishment, medical-device and site licenses and support DIN/NHP registrations and launchesApprove DIN, NHP, cosmetic and medical-device labels; review claims and advertising materials when requiredLead cross-functional quality activities through coaching, collaboration and technical expertise.
Support product availability and coordinate with Planning, Purchasing, Customer Service, Finance, Sales, Packaging and MarketingServe as the point person for Canadian quality issues and advise the business on compliance mattersAssess, 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 providersEstablish and maintain quality agreements with BDF Canada contractors and service providersAudit external partners such as Accuristix, Harling and RD Labs and BDF manufacturing sites including BMP and BMMOversee VAS batch release and documentation, finished-goods release records and complaint investigationsDevelop suppliers through re-audits and troubleshooting; initiate and verify effective CAPAReduce consulting costs by conducting external site audits directly where appropriateYour Tasks Lead country quality and compliance activities for products sold in CanadaMaintain the local QMS and author or approve BDF Canada SOPs,
quality reports and controlled recordsOversee Canadian product release, stability and microbiological testing, deviations, OOS investigations and CAPAMaintain Drug Establishment, medical-device and site licenses and support DIN/NHP registrations and launchesApprove DIN, NHP, cosmetic and medical-device labels; review claims and advertising materials when requiredLead cross-functional quality activities through coaching, collaboration and technical expertise.
Support product availability and coordinate with Planning, Purchasing, Customer Service, Finance, Sales, Packaging and MarketingServe as the point person for Canadian quality issues and advise the business on compliance mattersAssess, 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 providersEstablish and maintain quality agreements with BDF Canada contractors and service providersAudit external partners such as Accuristix, Harling and RD Labs and BDF manufacturing sites including BMP and BMMOversee VAS batch release and documentation,
finished-goods release records and complaint investigationsDevelop suppliers through re-audits and troubleshooting; initiate and verify effective CAPAReduce consulting costs by conducting external site audits directly where appropriateProduct Compliance: Manage medical-device lifecycle compliance and complaintsConduct internal PC audits and support Hamburg with DEKRA medical-device auditsMaintain MSDS information and ensure regulatory documentation remains currentCollaborate with R&D; and Hamburg on claims support, compliance and product-launch requirementsQuality 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 initiativesDrive risk-based decision making through trend analysis, complaint monitoring, CAPA effectiveness reviews and management-review activities.
Conduct internal GMP training and support audit readinessExecute and evaluate on-shelf store checks; drive corrective actions and complete monthly reportingManage MCS and Cal Labs Quality budgets for stability testing, microbiological testing and product releaseEnsure local processes align with North America, Global Quality and applicable Canadian requirementsMaintain continuous readiness for Health Canada, corporate, customer and third-party inspections through effective Quality System oversight, internal audit programs and timely resolution of identified gapsEnsure Quality Management System processes remain compliant, effective and aligned with North America, Global Quality and applicable Canadian regulatory requirements.
Manage interdepartmental relationships, deliverables, and stakeholders to achieve compliance
📌 Senior Quality Manager (Canada)
🏢 BEIERSDORF
📍 Canada