Supervisor, Quality Assurance

2 weeks ago

Montreal, Quebec, Canada Endo International Full time
Job Description

At Endo International, we are seeking a highly skilled Supervisor, Quality Assurance to join our team. This role is responsible for providing and leading quality systems at Paladin Pharma, a leading specialty pharmaceutical company.

The successful candidate will be responsible for managing deviations, CAPAs, complaints, product release, and Mock recalls. They will also be involved in the change control system, management review, and approval of GMP documentation and procedures.

This role requires a strong understanding of quality management systems and regulatory requirements. The ideal candidate will have a bachelor's degree in a health-related discipline or science and 5+ years of experience working in a Quality role in a GXP environment.

The Supervisor, Quality Assurance will work closely with cross-functional departments and suppliers to ensure compliance with current domestic and international GMPs and regulatory agencies.

Key Responsibilities:

  • Contribute to the development, management, and improvement of quality systems and procedures.
  • Assist with all aspects of quality systems, including Change Control, Deviations, Investigations, complaints, and CAPA systems.
  • Supervise the QA batch release functions for cGMP commercial and distribution activities.
  • Prepare and/or review controlled documents required for compliance.
  • Supervise and coordinate quality services staff and/or consultants.

Requirements:

  • Bachelor's degree in a health-related discipline or science.
  • 5+ years of experience working in a Quality role in a GXP environment.
  • 2+ years of experience with quality management systems.
  • Thorough understanding of fundamental GXP/ISO 13485 terminology, concepts, regulations, and industry standards.
  • Thorough understanding of quality systems and associated regulatory requirements and their application.
  • Ability to identify and troubleshoot routine technical problems.
  • Bilingual (French and English) with excellent oral and written communication skills in both languages.

What We Offer:

  • Hybrid work schedule.
  • Benefits package on first day.
  • Retirement Savings Plan (RRSP).
  • Employer contribution to employee RRSP (DPSP).
  • Employee Assistance Program (EAP).
  • Telemedicine program.
  • Employee Referral Program ($).
  • Free gym on site.
  • Free parking.

Commitment to Diversity, Equity, and Inclusion:

At Endo International, we are committed to cultivating and valuing each person's unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

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