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Quality Assurance Associate Director

Company: Kelly Services
Location: Nashville
Posted on: March 28, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company.

  • Support and maintain the Company's Quality Management System (QMS)
  • Oversight of the Company's vendor management program
  • Development of Quality Assurance team and individual development
  • Execution, coordination, and tracking of any assigned QMS procedures and related activities which may include internal audits, external audits, change management, document management, training management, batch review/release, deviation investigations, CAPAs, complaints, recalls, regulatory inspection management, quality risk management and management review coordination
  • Assembly, monitoring and/or presentation of QMS metrics updates and status reports
  • Develop and maintain compliant quality processes to support GMP activities
  • Participate in inspection readiness activities
  • Represent Quality Assurance during audits and perform internal and external audits
  • M.S (or equivalent degree) and 4-6 years of relevant work experience, or a BS or BA in a scientific or related field (or equivalent degree) and 8+ years of biotech/pharma industry experience
  • Demonstrated success as a team leader with a focus of team and individual development
  • Experience providing QA support and oversight of GMP manufacturing for development programs including batch release of drug product
  • Experience with multiple regulatory agencies across applicable GxPs during inspections
  • Experience with investigations, root cause analysis, and CAPA
  • Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience desirable
  • Requires a minimum of 6 years of experience in Quality Assurance or Regulatory Compliance Management
  • Experience in pharmaceutical manufacturing environment; excellent knowledge of cGMP, ICH, USP, and global compendial regulations and regulatory guidance
  • Excellent verbal and written communication skills, experience with scientific technical writing including authoring and revising SOP's or technical reports

Keywords: Kelly Services, Nashville , Quality Assurance Associate Director, Executive , Nashville, Tennessee

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