Product Compliance Manager - Quality

Janssen Inc., Canada is currently recruiting for a Manager, Product Compliance within the Canadian Quality team. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it. At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, pulmonary hypertension, and metabolic and chronic diseases. Motivated by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.com/canada for more information. The Manager, Product Compliance is responsible for managing the Janssen Inc. Drug and Medical Device Establishment Licensing and Narcotic Licensing Systems. In this role, you will: Design, implement, maintain, and continuously improve Janssen Inc. Quality System to ensure all products released in the Canadian Market are manufactured, packaged, tested, imported, and transported meet Health Canada and J&J Requirements. Ensure all key product support programs (Annual Product Review, Executed Batch Review, Confirmatory Testing, Unique Identifiers, Product Inspections, Internal and Health Authorities Inspections etc.) are managed effectively and efficiently. Manage the quality functions within the Purchasing Controls system including the Janssen Inc. Approved Supplier List (ASL) and the Approved Distributor List (ADL) and ensuring the Supplier and Distributor Quality Agreement Management System comply with Canadian Regulations and MRA frameworks. Ensure quality issues with associated Significant Safety Issues (SSI) are reported to Health Canada in accordance with the Food and Drug Regulations (FDR). Ensure SOPs at Janssen Inc. are reviewed, approved, implemented and are aligned with Corporate and Health Canada requirements. Ensure Janssen Inc. is kept up to date with J&J Affiliates and 3rd Party Electronic Systems / applications and processes, which ensure quality/regulatory are effectively and efficiently linked to global change management programs. Coach/mentor staff on the assessment of deviations/non-conformances (either internal or external) and other technical issues, to ensure that all issues are adequately understood, and that reviews and approvals are based on sound, risk-based rationales. Lead or participate in local, regional, or global cross functional teams to ensure adequate investigation, risk assessment, identification, and implementation of required actions to address product quality issues related to deviations and CAPAs. Lead or represent CQ for escalation of issues related to products marketed in Canada. Lead and/or participate in local, regional, or global cross-functional project teams including New Product Launches, Product Site Transfers and Acquisitions and Divestitures to accelerate and deliver innovative solutions, transform our business, and meet the needs of our patients. Contribute to the development and implementation of the strategic direction and priorities for the department. Manage, coach, and develop direct reports with coaching responsibilities and determine workload and priorities for resource allocation. Qualifications Job Knowledge and technical competencies: Required: BSc in Pharmacy, Chemistry, Microbiology, Biotechnology, or Biochemistry or equivalent (education or experience) Minimum of 5 years Pharmaceutical Quality / Regulatory experience Experience in a pharmaceutical importing/distributing environment Strong working knowledge of current GMPs, Food and Drug Regulations, Medical Device Regulations, Narcotics and Controlled Substances Regulations and interpreting their intent Knowledge of Post NOC changes and Product Formulation Understanding of Pharm processes (including manufacturing, packaging and validation) Proficient in Quality Issue Management Systems, Document Management Systems, SAP, and Microsoft Office applications Demonstrated sound judgment in dealing with risk on compliance matter and well defined problem solving and analytical skills Strong ability to negotiate and influence key stakeholders (internal & external) Strong ability to motivate, develop, and coach direct reports Demonstrates agility and adaptability in learning new technologies and business processes Lead multiple priorities including owning and balancing project management in conjunction with daily work Cultivate a culture of accountability, ownership, inventiveness, and empowerment Preferred: Experience in a pharmaceutical manufacturing environment is preferred Experience with Six Sigma / Process Excellence / Lean methodology / automation and tools is preferred Experience in Gene Therapy and Radiopharmaceuticals is preferred Janssen Inc. is based in Toronto, Ontario and supports a Flexible Work Arrangement to provide flexibility options for individual needs to support when, where and how we work. This position may require up to 10% travel. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of full COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Diversity and inclusion are central elements of the shared culture at Johnson & Johnson. Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential. Primary Location Canada-Ontario-Toronto-19 Green Belt Drive Organization Janssen Inc. (7710) Job Function Quality Requisition ID 2206039237W