Senior Manager Quality Assurance

Toronto, ON

  • 2021-07-02
  • Our client is a leading pharmaceutical company that specializes in dermatological treatments with a mission to advance dermatology through innovation and manufacturing. They are looking for a Senior Manager for Quality Assurance in the GTA.

    General Responsibilities:
    • Lead Quality Assurance within Canada, ensuring GMP, industry, corporate, and regulatory compliance.
    • Oversee and manage activities within Quality Assurance team.
    • Ensure company products comply with GMP, GDP, customer, company, and government expectations.
    • Achieve Quality Assurance operational objectives
    • Ensure best practice of Quality Compliance and Management between manufacturing sites and Canadian Affiliates.
    • Lead inspection-readiness program.
    • Be up to date on current compliance regulations and initiatives.
    • Provides and directs remediations of nonconformances.
    • Ensures nonconformance investigations lead to CAPA and prevention reoccurrence.
    • Leads post market surveillance activities.
    • Ensure quality management systems and subsystems meet regulatory, customer, and company requirements.
    • Maintains DEL, SL, MDEL, and other licence establishments.
    • Maintains GxP systems to comply with global Health Canada requirements.
    • Leads all GxP system implementation throughout entire cycle.
    • Other duties as assigned.
    Requirements:
    • Bachelor’s degree required (Sciences preferred)
    • 5+ years of experience in leadership/management role in a GMP environment
    • 10+ years of experience in manufacturing and laboratory processes of Prescriptions, Biologics, Over The Counter (OTC), Medical Device, Natural Health Products (NHP) industries.
    • Additional graduate certificate in pharmaceutical field is preferred
    • Experience with auditing (with auditing certification preferred)
    • Strong knowledge of HPFBI, GM and guidelines
    • Experience in pharmaceutical risk management
    • Basic knowledge of MS Software and computer/software operations
    • Ability to work cross-functionally and autonomously

    To apply, please submit your resume using the Apply Now button.

    We thank all interested applicants, however, only the candidates chosen for an interview will be contacted.