Johnson & Johnson Careers

Complaint Unit Team Lead

Markham, Canada
Quality Assurance


Job Description

Requisition ID: 4391181012

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 (JJMDC), 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.  JJMDC 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, orthopaedic implants, devices for women’s health including breast care, infection prevention and general-purpose sterilizers, hernia solutions, haemostatic products, cardiovascular and neurovascular diagnostics and treatment.  

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 (JJMDC), 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.  JJMDC 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, orthopaedic implants, devices for women’s health including breast care, infection prevention and general-purpose sterilizers, hernia solutions, haemostatic products, cardiovascular and neurovascular diagnostics and treatment.  

Role Summary:

You will lead and oversee the day to day Johnson & Johnson Medical Device Companies (JJMDC) Complaint Handling Unit (CHU) and the end to end complaint management program, while balancing the preparation, analyses, follow-up and closure of complaints and MPR/AE reports for domestic JJMDC products in compliance with company procedures and applicable regulations. You will assure data accuracy and regulatory reporting timelines are met; provide Product Safety and Surveillance support and expertise on cross-functional teams.

Key Responsibilities

Daily Activities:
Lead the creation and maintenance of the procedures defining the process for Complaint Handling and Mandatory Problem Reporting.
Manage local complaint reports for JJMC marketed and clinical products.
Performs preliminary complaint investigation by communicating with sales rep, customer/patient or affiliate. Enters data for all complaints in database, prepares affiliate reports and liaise with affiliates to assure timely investigation and closure of complaints.
Reviews analysis results for completeness, follow up with affiliates for additional information if required. 
Evaluates complaints for reportability; writes, reviews and files reports with Health Canada. Performs risk and quality assessments on mandatory problem and adverse event reports.
Collaborative liaison with customers and other internal and external business partners on complaint results.
Oversees the complaint sample returns process and provides assistance in preparation of shipments of complaint samples to affiliates for evaluation.
Collaborates with various functions (Franchise Subject Matter Experts (SMEs), Sales, Marketing, Supply Chain and Customer Logistics Services) to develop a strategy to address customer and regulators safety queries and concerns. Prepares and facilitates responses.
Takes the lead to develop and deliver complaint training to J&J employees and end-users.
Ensures all legal claims received are forwarded to the appropriate Legal contacts as per JNJ Corporate requirements. Implements proper processes at JJMC to meet legal requirements; responds to requests from legal counsel.
Leads and develops regular and on demand product quality complaint reports in support of Management Review and ongoing business needs.
Monitors and analyzes reports for potential signals and proactively communicates appropriately and develops an action plan with internal teams to avoid loss of business.
Hosts and leads Internal and External Audits as it pertains to CHU; ability to communicate regulatory and process as a SME during regulatory and internal inspections.
Represents Business Quality Complaints team on company-wide complaint handling initiatives and Quality Management Reviews, as required.
Provides coverage to other quality/compliance functions as needed.

Team Responsibilities
Lead and develop CHU team members to ensure the complaint management process is effective, continuously maintained and improved.
Responsible for team’s overall goals & strategy direction, coordination, development and evaluation.
Develop weekly/monthly goals and schedules to manage activities and team’s workload as required.

Strategy & Analytics
Design, implement, maintain and continuously improve JJMDC CHU to support business and comply with Health Canada and JnJ requirements
Regional representative in Global governance and strategy meetings to shape the end to end complaint management process
Partner closely with Commercial and Analytics team to create reports that measure key compliance metrics and are customer centric providing insights to the business.
Review changes to regulations and guidance documents and provide industry feedback during consultation period

 



Qualifications
University degree in Health Sciences or Nursing field is required.
Minimum 5 years of work experience in a regulated quality systems environment required. 5-7 years of experience preferred.
Experience in Medical Devices and or other regulated healthcare industry experience is required.
Post grad program in Quality is an asset.
Strong knowledge of Food & Drugs Act and regulations is required.
Demonstrated leadership capabilities are required.
Bilingualism is an asset.

Technical competency requirements:

Working knowledge of database management and appropriate personal computer software programs
Ability to assess and interpret safety information within the clinical context
Ability to problem solve and apply critical thinking.
Big picture orientation with attention to detail.
Sense of urgency, results and performance driven.
Works independently with minimum supervision.
Collaboration and teaming including cross-functional teams. 
Strong and productive relationships with people from other areas of the organization.
Negotiates and resolves conflicts effectively.
Ability to influence multiple partners.


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. 
Primary Location
Canada-Ontario-Markham-
Organization
Johnson & Johnson Inc. (7695)
Job Function
Quality Assurance
Requisition ID
4391181012