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QA Compliance Manager - Audit & Validation in Milton at Innomar Strategies

Date Posted: 4/12/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Milton
  • Job Type:
    Management
  • Experience:
    At least 1 year(s)
  • Date Posted:
    4/12/2018

Job Description

POSITION SUMMARY:
 
Under the general direction of the Director, Quality Assurance, primarily responsible for ensuring that Innomar/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.
 
This position is categorized as compliance critical and, as such, requires and is assigned specific responsibility for ensuring continual and proper compliance with all division, corporate and regulatory requirements.


 
PRIMARY DUTIES AND RESPONSIBILITIES:
  • 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,
  • Provides assistance to the Director, Regulatory Affairs
  • Performs other projects as assigned



 
 
 

Job Requirements

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:
  • Bachelor's degree required (preferably in scientific discipline)
  • Experience with Validation within a Pharmaceutical environment required
  • 1+ years of people management experience
  • Hands on Audit experience
  • Minimum of 10 years experience Regulatory Affairs and/or GMP Quality Assurance
  • Direct consumer or pharmaceutical regulatory experience
  • Regulatory Affairs or Quality Assurance Certification as asset


MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS: 
 
  • High level of organization and attention to detail.
  • Team player who respects all functional levels internally and externally.
  • Motivated and self-starter demonstrating a solution-orientated working style.
  • Effective leadership skills; required to lead and direct the work of others
  • Efficient in compiling, managing and interpreting data from various departments as well as documentation from clients and their affiliates.
  • 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.
  • Demonstrated aptitude in translating corporate policies into compliance – e.g., Corporate Security and Regulatory Affairs Policies & Procedures (CSRA P&Ps).
  • Excellent strategic, collaboration and presentation skills.
  • Effective interpersonal, written and verbal communication skills.
  • Knowledge of computers to operate effectively with Outlook, PowerPoint, Word and Excel.
  • Travel 20 %