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Associate Director, Quality Assurance

Expired Job

Elixir Recruitment Solutions Nashville , TN 37201

Posted 2 months ago

Job Description

Reporting to the Director of Quality, the Associate Director of Quality Assurance will be responsible for oversight of department activities, development of personnel, and ensuring quality of deliverables within his/her purview. This individual will be recognized as an expert in the principles and application of quality assurance and compliance and will be responsible for development of strategic group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements.



Responsibilities:

  • Support and maintain the client's Quality Management System (QMS)
  • Oversight of client'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

Requirements

  • 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 SOPs or technical reports

Benefits

Comprehensive benefits package with client paying 100% of healthcare premium. Eligible for profit sharing. Start-up company with room for growth.

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Associate Director, Quality Assurance

Expired Job

Elixir Recruitment Solutions