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Director QA Regulatory Affairs in Markham at Advantage Solutions

Date Posted: 5/4/2019

Job Snapshot

Job Description

Director QA Regulatory Affairs - Canada

At our Company, we grow People, Brands, and Businesses! We are seeking a highly dynamic Director of QA Regulatory Affairs to be responsible for all aspects of Quality Assurance and Regulatory Affairs as it relates to Drugs, Natural Health Products, and Medical Devices that are imported and/or distributed by the company in Canada. This role will be the sole decision-maker for all issues of quality or regulatory nature and be the primary contact for all dealing with Health Canada.

Take this opportunity to join North America’s leading business solutions provider and build your career working with amazing people in a growing industry! Apply today!

What we offer:

  • Full-Time Benefits (Health, Dental, Disability, Life, Lifeworks Program)
  • PerkSpot Discounts on Travel, Movies, Cell Phones and more
  • Training and Career Development
  • Generous Paid Time-Off 

Responsibilities:

  • Keep an up-to-date knowledge on the company and Health Canada regulations and policies applying appropriate implementation strategies where required.
  • Prepares and reviews regulatory documentation and submissions to regulatory bodies including, but not limited to: Drug Establishment Licenses, and Site Licenses/registrations.
  • Knowledge of provincial scheduling, Formulary, Pest Management Regulatory Agency (PMRA) preferred but not required.
  • Conduct a review of and track GMP documentation, including Master Batch Records, Certificates of Analysis, Annual Product Reviews, Stability, etc., for products marketed.
  • Drafts, revises and implements company procedures, policies and quality documents to ensure compliance across all departments.
  • Trains all personnel with QC and QA principles. Performs all QA functions including, but not limited to: batch/lot record review and release, raw data review, deviation/failure investigation, change evaluation, product sampling, and retention.

Qualifications:

  • Bachelor's Degree in Chemistry, Chemical Engineering, Biochemistry, Physical Sciences, Life Sciences, Pharmacology or Pharmacy or equivalent job-related experience required
  • 10+ Years of experience in regulatory affairs, compliance, quality assurance, and document management in the pharmaceutical or non-prescription drug industry or equivalent
  • Experience in an environment adhering to federal governmental regulation (i.e: Health Canada, PMRA, Consumer Products, etc.)
  • Strong GMP pharma/ Qualified Person in Charge (QPIC) experience
  • Prior experience interacting with auditors and regulators; Knowledge of country-specific regulatory requirements is an asset. Experience with preparing regulatory submissions is an asset
  • Experience in document control and management

The Company is one of North America’s leading sales and marketing agencies specializing in outsourced sales, merchandising, category management and marketing services to manufacturers, suppliers, and producers of food products and consumer packaged goods. The Company services a variety of trade channels including grocery, mass merchandise, specialty, convenience, drug, dollar, club, hardware, consumer electronics and home centers. We bridge the gap between manufacturers and retailers, providing consumers access to the best products available in the marketplace today.

The Company welcomes and encourages applications from people with disabilities.  The Company will provide reasonable accommodations, accessible formats, and communication support upon request to persons with disabilities who take part in all aspects of the recruitment and selection process.  If you require accommodation in connection with the application process, please contact: Recruiter, Talent Acquisition, for external applicants, or, a Supervisor for internal applicants.