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, escalate 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 Health Canada, corporate, customer and third-party inspections through effective Quality System oversight, internal audit programs and timely resolution of identified gaps
• Ensure 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 and continuous improvement.
Your Profile- 7+ years of related Quality or Regulatory Affairs experience in a regulated consumer-products environment
- Strong knowledge of Canadian DIN, NHP, cosmetic and medical-device requirements
- Strong knowledge of GMP, QMS, audits, complaints/ADRs, investigations, CAPA, change control and product release
- University degree in a relevant technical discipline; Biology, Engineering, Microbiology, Chemistry or related field preferred
- Strong analytical, problem-solving, decision-making and communication skills
- Strong project-management capability with strategic thinking and tactical focus
- Detail-oriented team player who organizes multiple priorities with reliable follow-through
- Strong oral and written communication; presents technical and regulatory information clearly
- Ability to lead, facilitate and influence cross-functional decisions
- Continuous-improvement mindset; resilient in dynamic situations; English required, French an asset
Additional informationHaving trouble applying? Go to www.BeiersdorfUSA.com to search our careers page.
