Quality Assurance Manager

1 month ago


Montreal, Quebec, Canada St-Amour & Associates, Senc. Full time

Job Title: Manager of Quality Services

Job Summary:

We are seeking a highly skilled Manager of Quality Services to join our team at St-Amour & Associates, Senc. The ideal candidate will have a strong background in quality assurance and a proven track record of leading teams in the pharmaceutical industry.

Key Responsibilities:

  • Provide oversight and support to quality systems, including technical transfer and validation initiatives, deviations, CAPAs, change controls, complaints, audits, stability, training, product release, and APQRs.
  • Maintain compliance for all products and systems, ensuring adherence to current domestic and international GMPs and regulatory agencies.
  • Lead quality support on projects assigned by managers, maintaining and providing continuous improvement of systems and products.

Requirements:

  • Bachelor's degree in science.
  • 8+ years of experience in a quality function in the pharmaceutical / biopharmaceutical industry.
  • 3+ years' experience in people management.
  • Excellent understanding of GMP/ISO 13485 terminology, concepts, regulations, industry standards, and trends and their application to complex problems.
  • In-depth understanding of a wide range of manufacturing technologies and dosage forms.
  • Ability to effectively lead teams in problem solving and continuous improvement.
  • Detail-oriented, able to work both independently and as part of a team.
  • Strong technical writing skills and a good command of general grammar and usage.
  • Demonstrates excellent interpersonal skills.
  • Bilingual (French and English) with excellent oral and written communication skills.

About Us:

St-Amour & Associates, Senc is an international Pharmaceutical company seeking a Manager of Quality Services to join our team. We offer a dynamic and challenging work environment, with opportunities for professional growth and development.



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