Senior Quality Manager
- Montreal, QC, Canada
Full-time
Applications open in a new tab.
Job details
- Job type
- Full-time
- Apply by
- Experience
- 7+ years of related Quality or Regulatory Affairs experience in a regulated consumer-products environment
- Posting language
- English
- Posted
Original job description
- 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.
- 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
- 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
- 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.
- 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
At Beiersdorf, we value diversity and aim to provide equal opportunities to all of our applicants – regardless of e.g. gender, sexual identity, nationality, ethnicity, religion or ideology, disability or age. We would therefore ask you to include only information and data in your documents which are relevant for the assessment of your application (e.g. curriculum vitae with relevant references and certificates). For instance, please feel free to upload your CV without a picture.
Beiersdorf North America - Recent Awards
- Winner of Comparably's Award for Best Company Outlook (2021, 2024, 2025)
- Winner of Comparably's Award for Best Company Work Life Balance (2025)
- Winner of Comparably's Award for Best Company Culture (2023, 2024)
- Winner of Comparably's Award for Best Company Compensation (2020, 2022-2024)
- Winner of Comparably's Award for Best Company Perks and Benefits (2024, 2025)
- Winner of Comparably's Award for Best Company for Happiness (2022,2023, 2024, 2025)
- Winner of Comparably's Award for Best CEO / General Manager (2020, 2024)
- Winner of Comparably's Award for Best Sales Team (2023, 2024, 2025)
- Winner of Comparably's Award for Best Leadership Teams (2020, 2021, 2023, 2025)
- Winner of Comparably's Award for Best Company for Diversity (2022)
Having trouble applying? Go to www.BeiersdorfUSA.com to search our careers page. Beiersdorf is an Equal Opportunity Employer.
More about this job
Responsibilities
Lead Canadian quality and regulatory compliance for consumer products, maintaining the local quality system, overseeing product release and testing, managing licenses and registrations, and ensuring inspection readiness. Manage supplier quality and audits, complaints and corrective actions, product compliance, quality budgets, and cross-functional initiatives to mitigate risks and improve performance.
Requirements
Requires at least seven years of related quality or regulatory affairs experience in a regulated consumer-products environment, with strong knowledge of Canadian product requirements, GMP, quality systems, audits, investigations, CAPA, and product release. A relevant technical university degree is preferred, along with strong analytical, communication, project-management, and cross-functional leadership skills; English is required and French is an asset.
Skills
- Quality Management Systems
- Canadian Regulatory Compliance
- Good Manufacturing Practices
- Auditing
- Supplier Management
- Complaint Investigation
- Root-Cause Analysis
- Corrective and Preventive Action
- Product Release
- Risk Management
- Change Control
- Medical-Device Compliance
- Project Management
- Cross-Functional Leadership
- Continuous Improvement
- Regulatory Affairs
Visa sponsorship
Not detected in the job text
Categories
- Management & Leadership
- Manufacturing
- Healthcare
- Science & Research
Keywords
- Canadian DIN Requirements
- Natural Health Products
- Cosmetics Compliance
- Medical Devices
- Good Manufacturing Practices
- Quality Management System
- Health Canada
- Drug Establishment License
- Site Licenses
- Product Registration
- Product Launches
- Product Release
- Stability Testing
- Microbiological Testing
- Deviation Management
- Out-of-Specification Investigations
- Corrective and Preventive Action
- Supplier Qualification
- Quality Agreements
- External Audits
- Internal Audits
- Complaint Trending
- Adverse Drug Reactions
- Risk-Based Decision Making
- Management Review
- Quality Planning
- Key Performance Indicators
- Safety Data Sheets
- Label and Claims Review
- Continuous Improvement