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Quality Services Director

2 months ago

Montreal, Quebec, Canada Paladin Pharma Inc. Full time
Quality Services Director Key Responsibilities
  • Supervise and coordinate Quality Services Team to ensure timely completion of assigned duties and responsibilities.
  • Manage changes management, product releases, product quality complaints including investigations, deviations, non-conformance system and CAPAs.
  • Establish and maintain the quality system, including GMP requirements for product launches, ISO 13485 certification, and related quality systems.
  • Develop and implement processes to manage non-MRA requirements and product return process.
  • Create and revise controlled documents required for compliance.
  • Recruit, train, develop, and retain a team of quality professionals to support key deliverables.
  • Develop and implement employee development and improvement plans to enhance team skills.
  • Manage subcontractors for the Quality Services Department to ensure compliance and quality.
Requirements
  • Bachelor's degree in science.
  • 8+ years of experience in a quality function in the pharmaceutical/biopharmaceutical industry.
  • 3+ years of experience in people management.
  • Excellent understanding of GMP/ISO 13485 terminology, concepts, regulations, industry standards, and trends.
  • In-depth understanding of various manufacturing technologies and dosage forms.
  • Ability to effectively lead teams in problem-solving and continuous improvement.
  • Strong technical writing skills and good command of general grammar and usage.
  • Excellent interpersonal skills.
  • Bilingual (French and English) with excellent oral and written communication skills.
About Paladin Pharma Inc.

Paladin Pharma Inc. is a leading specialty pharmaceutical company focused on acquiring or in-licensing new pharmaceutical products for the Canadian market. Our dedicated employees have made us one of Canada's pioneering specialty pharmaceutical companies.

We are an operating company of Endo USA, Inc., a highly specialized pharmaceutical company that brings quality branded and generic products to patients through excellence in development, manufacturing, and marketing.

To learn more about us, visit our website at

.