Posted to MedZilla on 1/18/2019

Randstad Pharma

Quality Assurance 20303-MZ


Job Title: Associate Director of Quality Assurance

Position Description

This is an exciting opportunity for a highly motivated individual to support core drug development activities for novel small molecule cancer therapeutics while playing an instrumental role in the growth of an emerging and well-positioned biotechnology company.

Position Responsibilities

  • Plan and perform domestic and international audits/inspections ensuring compliance with the FDA and other worldwide health authority regulations/guidelines, site SOPs, protocols, and industry standards
  • Prepare clear and concise written reports of audit observations including an assessment of compliance; adequacy of action plan; recommendations for corrective action; follow up activities as needed to monitor corrective action; and tracking corrective action commitments through closure
  • Interface directly with vendors in the negotiation of quality agreements and the management of quality-related issues
  • Manage quality assurance third parties contracted to perform functions in support of GxP activities
  • Review investigations conducted by third parties and providing company with input into CAPAs taken by the third party; track investigations to ensure resolution and closure
  • Review and approve drug substance and drug product manufacturing records, deviations, CAPAs, specifications, change controls, and test methods to ensure compliance with cGMP requirements
  • Disposition all GMP lots of drug substance and drug product manufactured for company
  • Manage training requirements to ensure all applicable personnel have the appropriate education, training, and experience to perform their job function and their qualifications are adequately documented

Position Requirements

  • B.S. in scientifically-related field
  • 7+ years of quality assurance experience, including planning and performing quality system audits and oversight of drug substance manufacturing, in a pharmaceutical development organization
  • Extensive knowledge of GxP regulations, API regulations, and SOP implementation
  • General scientific computer and software application proficiency


  • Medical, Dental, and Vision Insurance
  • 401K Plan
  • Life and AD&D Insurance

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