Quality Assurance Specialist, Vendor Mgmt

Alder Biopharmaceuticals   •  

Bothell, WA

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 49 days ago

Job Description:

This position is responsible for supporting the external vendor qualification program as well as the execution and oversight of the internal audit program at Alder Biopharmaceuticals. This role supports quality compliance and CMC regulatory activities in a clinical development and commercial setting. The position will be filled at a level commensurate with experience.

Specific responsibilities will include:

  • Support external vendor audits for Alder GxP vendors and suppliers and participate in audits as required
  • Review vendor audits to ensure compliance with all applicable regulatory requirements, company procedures and industry standards
  • Assess and track vendor observations to closure, implementing and developing appropriate CAPAs as required
  • Implement and manage the Supplier Corrective Action Program
  • Facilitate vendor qualification risk assessments and re-qualification activities
  • Partner with user departments to define requirements for on boarding new vendors (Vendor Selection)
  • Develop and evaluate vendor questionnaires as required
  • Maintain vendor files
  • Facilitate the development, assessment and review of vendor Quality Agreements
  • Develop, track and report metrics for the Vendor Qualification program
  • Execute internal audit program which includes:
  • Develop the annual internal audit schedule and coordinate with functional areas to schedule and conduct internal audits
  • Perform, track and close-out internal audits.
  • Develop and report internal audit metrics
  • Train internal auditors
  • Support SOP and Quality systems development, maintenance, and improvement
  • Support compliance activities associated with commercialization
  • Support Data Verification of Alder internal reports
  • Support Data Verification of Alder regulatory filings
  • Support Regulatory inspection readiness activities
  • Other duties as assigned

Requirements:

  • BS or BA Degree in Life Science
  • 7+ years in Pharmaceutical/Biotech Quality Assurance
  • Excellent working knowledge of cGMP requirements, FDA and ICH guidelines and industry best practices for biologics and parenteral applications
  • Experience with internal/external auditing and vendor management.
  • The successful candidate will have excellent written and oral communication skills, a flexible attitude with respect to work assignments, and the ability to proactively handle multiple tasks simultaneously
  • Strong computer skills, particularly with Microsoft Office Suite and Adobe Acrobat
  • Must possess skills and confidence to be able to effectively communicate internally and with personnel at multiple vendors
  • Travel to vendor locations, including international travel, may be required