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Director of Quality

Company: Ajulia Executive Search
Location: Gulfport
Posted on: March 20, 2023

Job Description:

Director of Quality - PharmaceuticalsFull time on-siteGulfport, MS

  • The Director of Quality must be responsible for developing, implementing, and maintaining a cGMP Quality System to meet the requirements of 21CFR210, 21CFR211, Regulatory Agencies, and customer expectations.
  • Must audit compliance to the quality system, policies and procedures.
  • Must oversee all Quality departments and provide necessary support.
  • Must actively take part in Interview processes, hire, and train new staff.
  • Provide constructive feedback and retraining as needed.
  • Must establish procedures and specifications of firms under contract are appropriate and followed.
  • Take responsibility for third-party services providers such as contract manufacturers, contract laboratories, etc.
  • Must establish manufacturing in-process controls are implemented.
  • Review, approve or reject all things cGMP related such as batch records and make the final decision to release a product lot into commerce.
  • The Director of Quality must investigate root cause for production related problems, complaints, and control record errors, discrepancies, and failure to meet specification, including quality attributes.
  • Must report on product, process and system risks, regulatory inspections and ensure responses are complete.
    • The Director of Quality must have a bachelor's degree.
    • Must have 10 years of ISO 9001 and Quality Management experience from a pharmaceutical manufacturing background.
    • Must have held a senior designation (Director/VP) for the last 5 years in a Pharma industry.
    • Must have 10 years of FDA regulations experience.
    • Must have 10 years of CGMP experience.
    • Must have excellent interpersonal and communication skills.
    • Must be willing to work on-site and willing to travel.
    • Must be fully vaccinated.
      --- Medical Insurance--- Dental Insurance--- Vision Insurance--- Direct Hire--- Paid time off.--- Relocation Assistance--- Salary: $115k-$130k/annum Ask for: Amrita Mukherjee

Keywords: Ajulia Executive Search, Gulf Port , Director of Quality, Executive , Gulfport, Mississippi

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