QA Manager

4 weeks ago

Durham, United States FUJIFILM Holdings America Corporation Full time
Overview

The QA Manager will be responsible for multiple and complex client programs within Quality Assurance. This role partners with internal and external stakeholders to ensure program management and overall product disposition activities, through management of programs and systems, meet site and client quality and compliance expectations.

External US

MAJOR ACTIVITIES AND RESPONSIBILITIES:

  • Manage the work and continuous improvements necessary to meet requirements for assigned compliance areas on time and right-first-time
  • Compliance subject matter expert (SME) and may lead compliance projects
  • Indirect management of internal stakeholders needed to support program requirements
  • Keep current with required site training and external compliance requirements
  • Set, monitor, and report progress on goals and development activities
  • Specific quality and compliance assignments should include, but are not limited to:
  • Responsible for product disposition, to include batch record review, data review, deviation / event review and closure, change management review / closure, facility assessments and manage external customer expectations for these document reviews for product release
  • Host external customer audits representing FDBU Quality Systems
  • Lead Quality compliance efforts for manufacturing readiness
  • Act as site SME during regulatory inspections for managed programs (including FDA and other audits)
  • Actively engage with all internal and external program members to ensure programs are supported in a compliant and timely manner
  • Can manage decisions within the SOP, std practice, and regulatory framework for compliance areas and can manage peer, subordinate and cross functional conflict resolution
  • Communicate cross functionally with peers, senior management, and external customers in oral, presentation, and written forms
  • Expert problem solving skills to identify and solve problems within the SOP, Std Practice, and regulatory framework. Able to manage cross-functional teams to investigate, recommend improvements to management, and monitor effectiveness of improvements
  • Demonstration of leader behaviors, consistently promotes positive inclusive behaviors, consistently promotes positive team attitude, and supports business objectives

Education/Background Requirements:

  • Minimum of Bachelor's degree required; Science, or another technical field is preferred but not required
    • Bachelor's + 10 years of quality related experience
    • MS/PhD +4 years of quality related experience
  • Previous batch release experience preferred
  • Previous SAP and TrackWise experience preferred
  • Experience with direct and indirect management of cross-functional teams

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 - 130 and Export Administration Regulations in 15 C.F.R. Part 730 - 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail  FDBUHR@ .

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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