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Manager, Quality R&D

Jubilant Pharma, LLC
Quebec, QC
Management
Posted 13 days ago

Qualifications :

ENGLISH

Join Jubilant Radiopharma as the Manager of Research and Development Quality Assurance and become an essential part of our dynamic team!

At Jubilant Radiopharma, we are pioneers in providing innovative solutions in drug development and clinical trials. As the Manager of R&D Quality Assurance, you will play a pivotal role in ensuring the quality and compliance of our products, supporting our growth and commitment to excellence.

Why Join Us:

  • Impactful Work : You will oversee the development and optimization of Quality Assurance processes, ensuring compliance with regulatory requirements and supporting the seamless flow of documents for effective technical transfer.
  • Innovative Environment : Be part of a cutting-edge environment where you'll collaborate with talented professionals in drug development and medical device innovation.
  • Professional Growth : Take your career to new heights with opportunities for learning and development in a dynamic and supportive workplace.
  • Industry Leader : Join a company at the forefront of the industry, making a difference in healthcare through our commitment to quality and innovation.

Responsibilities:

  • Oversight and Management : Provide direction and managementfor Quality Assurance in drug development programs, ensuring compliance with regulatory standards.
  • Coordination : Coordinate all Quality Assurance activities for new drug and medical device development programs, facilitating smooth document flow and approval processes.
  • Project Support : Provide project support to ensure phase-appropriate QA requirements are met, including reviewing and approving SOPs, protocols, and acceptance reports.
  • Collaboration : Coordinate with internal and external partners to ensure timely completion and release of protocols and clinical trial material.
  • Technical Transfer : Provide guidance and support during the technical transfer of products from R&D to commercial manufacturing.

Qualifications:

  • Bachelor's degree in Science from a recognized Canadian university.
  • Over 7 years of GMP experience with more than 3 years supporting drug development.
  • Experience in medical devices and familiarity with FDA/EU regulated environments.
  • More than 3 years of QA experience, particularly in radio pharmaceuticals and ISO 13485.
  • Strong understanding of cGMPs, European regulatory requirements, and relevant scientific principles.
  • Excellent interpersonal skills for effective collaboration with cross-functional teams and regulatory agencies.

Join us in our mission to deliver quality and innovation in drug development and clinical trials. Apply now to be part of our team and make a meaningful impact in healthcare!

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