Compliance Lead - Customer Logistics Services, Johnson & Johnson Medical Companies, Markham, ON-0710141127
Description
Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.
Johnson & Johnson Medical Companies (JJMC), a division of Johnson & Johnson Inc., markets and distributes medical device and diagnostic solutions for use in institutional and primary health care settings across Canada. JJMC focuses on providing minimally invasive treatment options spanning various medical procedures and disease states. Among the products represented by its various business units are: surgical instruments, orthopedic implants, devices for women’s health including breast care, infection prevention and general purpose sterilizers, hernia solutions, hemostatic products, cardiovascular and neurovascular diagnostics and treatment.
Position Overview
Lead role under direction from the Director Distribution Operations in the management and execution of the compliance requirement for multi site (3 facilities), all sector (Janssen Pharmaceutical, LifeScan, Animas, J&J Medical Companies (Global Surgery / DePuy Synthes) and Consumer distribution operations for CLS Canada. Co-leads or leads audit readiness and remediation activities for planned and unplanned audits from but not limited to Health Canada (DL, MDEL,OCS), Corporate Enterprise Regulatory Compliance (ERC), Sector Audits, QScan, and local self audits of the Quality System
Major Responsibilities:
Compliance
Leads issues log process and review meeting for each of the operating companies including tracking, analyzing and trending including the elevation decision process.
Leads dispute resolution process and review meeting for each of the operating companies including analyzing and trending including the elevation decision process.
Co-leads with Quality and Compliance the Change Control, Non-Conformance, CAPA weekly review and tracking meetings including metrics development and publication.
Leads Distribution Operations Change Control, NC and CAPA administrative process including tracking and elevation decisions.
Tracking and issuance of regular compliance scorecards for CLS Distribution Operations.
Co-leads with Quality and Compliance and 3PL Quality the internal audit schedule and process including remediation activities.
Co-leads with Quality and Compliance audit readiness and preparation for external and regulatory agency audits including remediation activities..
Leads audit readiness and remediation for Risk Management / Health & Safety audits.
Leads Distribution Operations activities and sits on partner market action teams as required for stop ship and recall activity and manages relationship with 3rd party recall service provider.
Responsible for operational execution of on-site labeling requirements to meet regulatory requirements (IFU’s NFHU, SAP)
Supply & Equipment Maintenance
Manages internal preventative maintenance program for coolers, freezers and facility including related temperature mapping requirements.
Manages internal quality system programs for pest control and sanitation
Qualifications
Business or Science Degree or equivalent
Quality & Compliance industry experience of 3 to 5 years required
Cross sector / industry experience in Distribution Operations of 3 -5 years an asset
Proficient in advanced Excel, PowerPoint and Word.
Strong technical skills: SAP, JDE, Cognos
Project Management experience an asset
Process Excellence / Continuous Improvement training an asset
Due to the scope of the job responsibilities the incumbent will be required to travel at the local level. Occasional national and regional travel may also be required 1 – 2 times per year.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. 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.
J2W:LI_NA
Primary Location:North America-Canada-Ontario-Markham
Organization: Johnson & Johnson Inc. (7695)
Job Function: Strategic Sourcing/Logistics
Description
Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.
Johnson & Johnson Medical Companies (JJMC), a division of Johnson & Johnson Inc., markets and distributes medical device and diagnostic solutions for use in institutional and primary health care settings across Canada. JJMC focuses on providing minimally invasive treatment options spanning various medical procedures and disease states. Among the products represented by its various business units are: surgical instruments, orthopedic implants, devices for women’s health including breast care, infection prevention and general purpose sterilizers, hernia solutions, hemostatic products, cardiovascular and neurovascular diagnostics and treatment.
Position Overview
Lead role under direction from the Director Distribution Operations in the management and execution of the compliance requirement for multi site (3 facilities), all sector (Janssen Pharmaceutical, LifeScan, Animas, J&J Medical Companies (Global Surgery / DePuy Synthes) and Consumer distribution operations for CLS Canada. Co-leads or leads audit readiness and remediation activities for planned and unplanned audits from but not limited to Health Canada (DL, MDEL,OCS), Corporate Enterprise Regulatory Compliance (ERC), Sector Audits, QScan, and local self audits of the Quality System
Major Responsibilities:
Compliance
Leads issues log process and review meeting for each of the operating companies including tracking, analyzing and trending including the elevation decision process.
Leads dispute resolution process and review meeting for each of the operating companies including analyzing and trending including the elevation decision process.
Co-leads with Quality and Compliance the Change Control, Non-Conformance, CAPA weekly review and tracking meetings including metrics development and publication.
Leads Distribution Operations Change Control, NC and CAPA administrative process including tracking and elevation decisions.
Tracking and issuance of regular compliance scorecards for CLS Distribution Operations.
Co-leads with Quality and Compliance and 3PL Quality the internal audit schedule and process including remediation activities.
Co-leads with Quality and Compliance audit readiness and preparation for external and regulatory agency audits including remediation activities..
Leads audit readiness and remediation for Risk Management / Health & Safety audits.
Leads Distribution Operations activities and sits on partner market action teams as required for stop ship and recall activity and manages relationship with 3rd party recall service provider.
Responsible for operational execution of on-site labeling requirements to meet regulatory requirements (IFU’s NFHU, SAP)
Supply & Equipment Maintenance
Manages internal preventative maintenance program for coolers, freezers and facility including related temperature mapping requirements.
Manages internal quality system programs for pest control and sanitation
Qualifications
Business or Science Degree or equivalent
Quality & Compliance industry experience of 3 to 5 years required
Cross sector / industry experience in Distribution Operations of 3 -5 years an asset
Proficient in advanced Excel, PowerPoint and Word.
Strong technical skills: SAP, JDE, Cognos
Project Management experience an asset
Process Excellence / Continuous Improvement training an asset
Due to the scope of the job responsibilities the incumbent will be required to travel at the local level. Occasional national and regional travel may also be required 1 – 2 times per year.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. 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.
J2W:LI_NA
Primary Location:North America-Canada-Ontario-Markham
Organization: Johnson & Johnson Inc. (7695)
Job Function: Strategic Sourcing/Logistics