7 days old

Director of Quality Assurance

Bend Bioscience
Bend, Oregon 97703
  • Job Type
    Employee
  • Job Status
    Full Time

Bend BioScience is focused on research, development, and clinical production of non-sterile drug products and intermediates for the pharmaceutical industry. As a start-up, this position will be instrumental in defining a quality culture and building systems, policies, and procedures to define a compliant organization with quality instilled throughout all operational aspects. The individual will need to be able to apply their regulatory and quality experience to GMP requirements for investigational new medicines for use in the US and Europe.


The Director of Quality Assurance works collaboratively with other departments to execute with high quality standards and mitigate and resolve potential quality issues by:

  • Provide leadership and guidance on quality to operations and technical functions for a dynamic early phase clinical focused CDMO organization focused on investigational new medicines
  • Develop, implement, and administer eQMS software system
  • Lead the review and approve investigations, incidents, CAPAs, and laboratory investigation reports
  • Lead and manage the GMP training program
  • Lead and manage supplier and material qualifications
  • Provide leadership and point-of-contact in regulatory and client audits
  • Ensure organizational compliance with regulatory guidelines, company policies, procedures, work instructions, and training requirements.
  • Represent Bend Bioscience quality and regulatory policy to the clients
  • Support quality and regulatory aspects of client programs.
  • Collaborate with clients and suppliers on quality, regulatory, and technical issues
  • Drive site specific continuous improvements
  • Ensures Bend Bioscience is following cGMP guidelines and ensures the staff Is following Bend Bioscience Quality policies and SOP

Requirements

  • Thorough understanding of GMP Regulations (FDA, EU, JP) and specific regulatory guidance, applicable to early phase clinical requirements and the production of investigational new medicines
  • Proficiency in MS Office applications; Word, Excel, Outlook
  • Strong organizational skills
  • Strong oral and written communication skills
  • Minimum 10 years of experience in the pharmaceutical industry, including a minimum of 7 years of QA experience
  • Experience in drug product manufacturing and CDMO space preferred

Categories

Posted: 2022-09-21 Expires: 2022-10-21

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Director of Quality Assurance

Bend Bioscience
Bend, Oregon 97703

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