FUJIFILM Corporation

QA Manager, Audits and Inspections

FUJIFILM Corporation

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Mid-LevelSenior

About the role

  • Host and manage client audits, regulatory inspections, internal audits, and supplier assurance.
  • Handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance.
  • Report to Director, Quality Assurance Compliance.
  • Mentor and provide direction to the QA compliance organization; develop, motivate and lead direct reports towards organizational and individual goals.
  • Work collaboratively with management of other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles.
  • Provide QA leadership and support in conducting audits and hosting audits/inspections.
  • Support client due diligence, Quality audits and regulatory inspections to enable new business growth.
  • Work with Quality management to implement quality systems enabling cGMP manufacturing of pre-clinical to commercial products.
  • Manage and report all aspects of a fully functional GxP-QA audit program for clinical and commercial CDMO.
  • Manage external and internal Audit Programs; prepare for audits, conduct internal audits, host client audits, and coordinate responses to client audits and regulatory inspections.
  • Ensure supporting documentation, tracking and verification of CAPA commitment implementation.
  • Provide and manage metrics and implementation tracking of corrective and preventive actions following audits and inspections.
  • Support Global Supplier Assurance and represent the Texas site in joint audits.
  • Perform all other duties as assigned.

Requirements

  • Master’s degree with 5+ years’ industry experience in a GMP/GxP, or a comparable federally regulated environment.
  • Bachelor’s degree 7+ years’ industry experience in a GMP/GxP, or a comparable federally regulated environment.
  • 4+ years of experience in supervisory or managerial role.
  • Experience with direct dealings with the FDA, MHRA and other European or world-wide regulatory agencies.
  • Certified Quality Auditor preferred.
  • Degree in Biology, Chemistry or Engineering preferred.
  • Excellent written and oral communication skills.
  • Excellent organizational, analytical, data review and report writing skills.
  • Ability to set personal performance goals and provide input to departmental objectives.
  • Develop staff to maximize contributions to the team and the company.
  • Ability to multitask and easily prioritize work.
  • Ability to work independently with little supervision.
  • Proficient in Microsoft Excel, Word and PowerPoint.
  • All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
  • Must be willing to work flexible hours.
  • Ability to work weekends and off-shift hours, as needed to support manufacturing activities.
  • Must be willing to travel occasionally, as needed.
  • Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning material and appropriate shoes required in most areas associated with this position.
  • Lifting up to 25 pounds on occasion.
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
  • Attendance is mandatory.