Commercial Quality; CQ Product Compliance Process Lead

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Quality

Quality Systems

Professional

Toronto, Ontario, Canada

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

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The CQ Product Compliance Process Lead is responsible for the support/ownership of product compliance programs to establish and maintain regulatory and quality compliance in accordance with Johnson and Johnson Innovative Medicines and Health Authorities requirements for all imported/distributed product in the Canadian Market.

This role manages critical quality processes, driving end‑to‑end quality oversight of assigned products and projects, manages change controls, evaluates key GxP documentation, supports compliance initiatives across the LOC and affiliate sites, and drives process improvements by partnering closely with internal and external teams to maintain robust product quality and operational excellence.

• Maintain compliant product specifications/standards and manage associated changes, including assessment of GMP and regulatory filing impacts.
• Ensure timely and compliant product release to the Canadian market.
• Review analytical, manufacturing, and packaging documentation to recommend product disposition.
• Monitor ongoing product compliance through review of APQRs, stability reports, supplier documentation, and executed batch records.
• Lead change controls, ensuring timely assessments, documentation, and closure.
• Lead new product launches and site transfers, ensuring all documentation aligns with Health Canada marketing authorizations.
• Provide SAP expertise and authorize product inventory release.
• Manage product return assessments and oversee complaint intake, follow-up, and trend evaluation.

• Support LOC and affiliate sites with compliance and quality improvement initiatives.
• Develop and improve processes and metrics to ensure regulatory and quality performance.
• Evaluate changes to master production documentation in alignment with regulatory requirements.
• Conduct self‑inspections and support Health Canada Inspections and Corporate audits.
• Supporting quality documentation such as Supplier Assessments, GMP compliance documentation for DEL, Supplier Quality Agreements, and Health Canada/J&J audit support.

• Act as a QA subject‑matter expert and “go‑to” resource for cross‑functional teams.
• Lead, investigate, and resolve non‑conformances (NCs) and CAPAs, coordinating across functions and suppliers.
• Provide expert rationales for product disposition, risk assessments, audit responses, and compliance decisions.
• Troubleshoot complex quality and compliance issues using technical expertise and creative problem‑solving.

• Support the supplier lifecycle—including selection, qualification, maintenance, and…