Director Quality Assurance

4 weeks ago

Mississauga, Canada 3 Step Recruitment Inc. Full time
Director - Quality Assurance & Regulatory

Our client, a global pharmaceutical company is searching for an experienced and dynamic Director - Quality Assurance & Regulatory. This is a hybrid opportunity in Mississauga.

This position plays a crucial role in ensuring compliance with regulatory standards and maintaining the highest quality standards for pharmaceutical products. The position is responsible for developing and implementing regulatory and quality systems in compliance with GMP and Health Canada Guidelines.

Salary: $200,000 + bonus of 20%.

Hours of operations: Monday to Friday: 9:00am - 5:00pm.

Location: Mississauga.

Working arrangement: Hybrid.

Benefits: Health, dental, vision, disability, life insurance and RRSP match.

Responsibilities

  • Align and execute regulatory strategies for product registrations and ensure compliance with Health Canada regulations.
  • Oversee the preparation, compilation, and submission of regulatory documents to Health Canada.
  • Determine and communicate submission and compliance requirements to key stakeholders and gather and compile necessary data.
  • Manage the Drug Establishment License application process.
  • Serve as a liaison between Health Canada and the organization.
  • Lead approval of assigned new products and claims.
  • Monitor regulatory and external environment.
  • Anticipate and proactively act on changes to the Canadian Food and Drug Act Regulations.
  • Maintain robust Quality Management System in accordance with Canadian regulatory requirements.
  • Improve and enhance the Quality Management System, identifying areas for optimization and ensuring alignment with industry best practices.
  • Monitor regulatory developments, assess their impact on the company, and provide guidance to cross-functional teams to ensure ongoing compliance.
  • Ensure accuracy and compliance of activities as defined by the organization’s SOPs.
  • Perform all activities related with batch release, final product disposition and maintain documents as per the Health Canada requirements.
  • Manage confirmatory testing program as per the company procedures and Health Canada guidelines.
  • Responsible for handling deviation management, change control and implementation of corrective action.
  • Coordinate with corporate quality and regulatory for various policy and procedure implementation.
  • Provide weekly and monthly report and participate in review meeting for progress.
  • Other duties as required.

Qualifications

  • 10 years of combined experience in regulatory affairs and quality assurance within the pharmaceutical industry.
  • Bachelor's degree in a relevant scientific discipline.
  • Advanced degree (MSc, PhD) preferred.
  • In-depth knowledge of Canadian regulatory requirements and quality standards.
  • Proven success in managing regulatory submissions and quality systems.
  • Strong leadership abilities.
  • Outstanding communication and interpersonal skills.
  • Results-oriented mindset.
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