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QA Compliance Manager in Milton at Innomar Strategies

Date Posted: 12/31/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Milton
  • Job Type:
  • Experience:
    At least 10 year(s)
  • Date Posted:
    12/31/2018

Job Description

Under general direction of the Senior Quality Assurance Manager GMP, the QA Compliance Manager is primarily responsible for ensuring that Innomar and AmerisourceBergen Canada (ABCC) operates and is in compliance with GMP, Narcotic, Medical Devices and Natural Health Products regulations/requirements as set out by Health Canada and Corporate policies. This is a leadership position, responsible for preparing, implementing, communicating, and coordinating regulatory projects, plans and schedules with business development project team members for assigned products.

 

What You’ll Do:

  • Directs the QA/QC Coordinator and provides guidance on responsibilities
  • Ensure the Innomar & 3PL facilities, operates and is in compliance with the Good Manufacturing Practices, Medical Devices, Narcotic and Natural Health Products regulations and Corporate policies
  • Ensure that all activities and transactions occurring at the Innomar & 3 PL facilities are in compliance with SOP’s relevant to the Narcotic, Natural Health Products, Medical Devices and GMPs
  • Ensure the Regulatory department is in compliance with Health Canada regulations and guidelines
  • Implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
  • Responsible for the coordination of regulatory filings with Health Canada and other regulatory agencies
  • Review regulatory documents such as applications, submissions, amendments, Annual reports, supplements, product dossiers
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly
  • Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance
  • Assists in product launch activities as required
  • Works with other functional areas to resolve issues related to information for regulatory submissions
  • Manage customers' registration process
  • Oversees quality audits with Health Canada, customers and third party auditors
  • Participate in New Business Development, Consulting, Health Outcomes activities and Strategic Planning
  • Provides Regulatory and Quality Assurance guidance to potential new clients
  • Provides support to client such as product importation

Job Requirements

  • Bachelor's degree required (preferably in scientific discipline)
  • Minimum of 10 years experience in Regulatory Affairs and/or GMP Quality Assurance
  • 1+ years of people management experience
  • Experience with Validation within a Pharmaceutical environment required
  • Hands on Audit experience
  • Direct consumer or pharmaceutical regulatory experience
  • Must have full and complete knowledge of the Good Manufacturing Practices, Natural Health Products, Narcotic and Medical Device regulations as they relate to their relative activities
  • Regulatory Affairs or Quality Assurance Certification is an asset