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Markham, Ontario, Canada · Hybrid
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Markham, Ontario, Canada · Hybrid
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Markham, Ontario, Canada · On-site
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Markham, Ontario, Canada · On-site
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Markham, Ontario, Canada · Hybrid
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less in…
Skills: Tableau, Power BI, Database Modelling, SAP, Excel
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Lead Commercial Quality activities for the Canada market to ensure compliance with regulatory requirements and quality system standards. Partner with cross-functional teams to support product distribution, post-market surveillance, and audit readiness.
Requires a Bachelor's degree in a scientific or quality field and 8-10 years of progressive experience in Quality, Regulatory, or Compliance roles. Proficiency in Canadian regulatory requirements and experience with health authority inspections are highly preferred.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJohnson & 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.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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At Johnson & Johnson Innovative Medicine, we innovate with purpose, to lead where medicine is going. The experiences of patients around the world inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science with compassion, we confidently address the most complex diseases of our time and develop the potential medicines of tomorrow. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way. https://bit.ly/3reuMvK
