Job Function: Quality
Job Sub Function: Customer/Commercial Quality
Job Category:Professional
All Job Posting Locations:Markham, Ontario, Canada
Job Description:Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
DePuy Synthes is recruiting for a(n) Sr. Manager, CQ Lead Canada in Commercial Quality, located in Markham, Ontario, Canada.
Job Overview
The Sr. Manager, CQ Lead Canada is responsible for leading Commercial Quality activities for the Canada local market. This role ensures that commercial, distribution, and post-market activities comply with applicable regulatory requirements, quality system standards, and internal policies. The position has a significant impact on patient safety, regulatory readiness, and business performance by serving as the senior Commercial Quality leader for Canada and partnering closely with Commercial, Regulatory Affairs, Supply Chain, and Global Quality teams.
Key Responsibilities
- Lead and oversee Commercial Quality activities for the Canada market in alignment with global quality and compliance strategies.
- Ensure adherence to Canadian regulatory requirements, internal policies, and quality system standards across commercial operations.
- Serve as the primary Commercial Quality point of contact and escalation lead for the Canada local operating company.
- Partner with Commercial, Regulatory Affairs, Quality, and Supply Chain teams to support compliant product distribution and lifecycle activities.
- Support post-market surveillance activities, including complaint handling, vigilance, and field action coordination.
- Lead audit and inspection readiness, including internal audits, external audits, and health authority inspections.
- Monitor quality trends, risks, and performance metrics and drive corrective and preventive actions.
- Lead, coach, and develop Commercial Quality team members, fostering a strong quality culture.
Qualifications
Education:
- Bachelor's degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or a related discipline (required).
- Advanced degree in a scientific, quality, or regulatory field (preferred).
Experience and Skills:
Required:
- Typically 8-10 years of progressive experience in Quality, Regulatory, or Compliance roles within a regulated industry.
- Strong working knowledge of quality system and regulatory requirements impacting commercial operations.
- Experience supporting audits, inspections, and health authority interactions.
- Demonstrated ability to lead local quality execution and influence cross-functional stakeholders.
Preferred:
- Experience in medical devices, healthcare, or other highly regulated industries.
- Familiarity with Canadian regulatory requirements and Health Canada expectations.
- Experience working in a global or matrixed organization.
- Exposure to post-market surveillance and distribution quality activities.
- Quality or Regulatory certifications (e.g., RAC, ASQ).
- Strong analytical, organizational, and problem-solving skills.
- Effective written and verbal communication skills.
Other:
- Language: English required; French preferred.
- Travel: Limited; occasional domestic or regional travel.
- Certifications: Quality or Regulatory certifications preferred but not required.
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Required Skills: Preferred Skills:Business Alignment, Compliance Management, Consulting, Continuous Improvement, Fact-Based Decision Making, ISO 9001, Organizing, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Stakeholder Engagement, Standard Operating Procedure (SOP), Technical Credibility
