Supervisor, QRA Management

Cardinal Health Canada is currently seeking a Supervisor, QRA Management for a permanent opportunity within out head office in Vaughan, Ontario.

This role is responsible for managing the postmarket regulatory compliance program at Cardinal Health Canada.  This includes the development and deployment of policies, procedures and programs designed to minimize risk, enable compliant business operations, products and services and drive uncompromised supply chain integrity. 

Key Responsibilities

  • Demonstrates knowledge of Health Canada regulatory requirements and utilizes depth and breadth of experience to assess regulatory changes, risk and business impact.
  • Oversee the product hold and recall process in Canada in alignment with Corporate policies and procedures.
  • Responsible for the complaint handling and vigilance reporting process for Cardinal Brand product and supplier brand product in alignment with the Corporate policies and procedures.
  • Develop, implement and maintain standard operating procedures, programs and electronic systems for holds, recalls and complaints in accordance with Health Canada regulations and Corporate policies and procedures.
  • Act as a liaison with Health Canada for recalls or during regulatory inspections.
  • Monitors changes to local regulations in order to implement new Company procedures or update existing procedures to facilitate compliance
  • Applies thought leadership and expertise to assess, evaluate, manage, mitigate and balance risk and enhance business performance.
  • Act as a supervisor, coach and mentor to a team of specialists.
  • Provides ongoing guidance and direction to operations and other business functions regarding regulatory and quality matters.

Experience.

  • University degree in a relevant Science discipline.
  • Minimum of 5-7 years experience in a Regulatory, Compliance or Quality role within the medical device or pharmaceutical industry (distribution or manufacturing).
  • Minimum 2 years of experience supervising people.
  • Applied comprehensive knowledge of the Health Canada Food and Drug Act, Canadian Medical Devices Regulations, Drug Regulations and GMP, Natural Health Product Regulations, Cosmetics and Consumer Regulations. 
  • Experience managing and motivating people;
  • Highly organized, problem solving, analytical and focused;
  • Proven communication skills (verbal, written and presentation skills).

Cardinal Health is committed to employment equity and encourages applications from women, visible minorities, Aboriginal peoples and persons with disabilities.