Quality Assurance eQMS Manager
Location: College Station
Posted on: June 23, 2025
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Job Description:
The work we do at FUJIFILM Diosynth Biotechnologies Texas has
never been more important—and we are looking for passionate,
mission-driven people like you who want to make a real difference
in people’s lives. From developing the next vaccine to advancing
cell and gene therapies, we collaborate with industry leaders to
tackle complex challenges and deliver meaningful solutions. If
you’re ready to help transform the future of medicine, join
FUJIFILM Diosynth Biotechnologies. We offer a flexible work
environment and we’re proud to cultivate a culture that will fuel
your passion, energy, and drive—what we call Genki. Our
state-of-the-art biomanufacturing facility is located in in College
Station, Texas, which combines a small-town feel with vibrant
culture, top-notch schools, and close proximity to big city life.
Nestled between major hubs, it’s a dynamic location that blends
convenience with innovation. Key Responsibilities: QMS
Administration & Compliance o Oversee the installation,
configuration, and maintenance of the eQMS. o Ensure the eQMS
remains compliant with regulatory standards and certifications
including FDA (21 CFR 210, 211, 820) Annex 11, CFR part 11 and
other regulation as applicable. o Maintain controlled copies of
quality documents and facilitate document retrieval during
regulatory inspections. o Execute document and change control
processes to ensure standardization and accuracy. o Identify and
implement operational improvements to enhance eQMS efficiency.
System Support & Troubleshooting o Provide troubleshooting support
to end users and coordinate with system owners or vendors to
resolve issues. o Administer user accounts, roles, and system
functions per global and local eQMS procedures. o Work with IT and
Quality personnel to ensure system compliance and security. o
Develop and execute validation scripts as needed for change control
issues. o Implement system workflows and reports to meet business
needs. o Support system validation by collaborating with local and
global CSV teams, reviewing validation documentation, and
conducting user acceptance testing (UAT) to ensure compliance and
functionality. o Develop, review, approve, and deliver eQMS
training materials to ensure effective system usage and compliance,
identifying and addressing training needs as required. Leadership:
• Lead and mentor a team of eQMS professionals, ensuring adherence
to quality standards. • Represent the eQMS group in
cross-functional meetings and global quality initiatives. • Serve
as the FDBT QA point of contact on the Global eQMS projects. •
Collaborate with management of other site functions to instill a
‘Quality Culture’ by coaching on the application of CGMP Principles
including the underlying rationale. • Collaborate with Business
Process Owners and system SMEs across departments to optimize eQMS
functionality, ensure compliance, and drive continuous improvement.
• Manage team resources effectively, ensuring strategic time
management, prioritization, and adaptability to navigate project
conflicts and shifting timelines. • Conduct performance reviews for
direct reports. Audit and Regulatory Support: • Review and approve
changes to the validated state of systems through change control
processes. • Develop, revise, and manage eQMS SOPs, deviations,
CAPAs, change controls and Audit outcome. • Support client due
diligence, quality audits, and regulatory inspections. • Perform
other duties as assigned. Required Skills & Abilities: • Proven
ability to lead teams, implement process improvements, and ensure
regulatory compliance. • Strong experience with eQMS solutions
(e.g., Veeva, MODA, LIMS, Compliance Wire, TrackWise). • Strong
working knowledge of data privacy regulations in the US and Europe,
including GDPR. • Expertise in FDA, cGMP, ISO 13485 • Experience
with Quality Systems (Deviation, OOS, CAPA, Change Control, Audits,
etc.). • Strong organizational skills with excellent attention to
detail and ability to manage multiple priorities. • Strong
problem-solving, project management, and decision-making skills. •
Proficiency in MS Office (Word, Excel, Outlook) and quality system
software. • Effective communication and collaboration skills across
cross-functional teams. • Understanding of business continuity and
risk management principles. • Strong analytical and problem-solving
skills. • Certifications: Certified Quality Manager (CQM),
Certified Quality Engineer (CQE) or similar certification preferred
Preferred Experience, Skills & Abilities: • Experience in
developing cGMP training materials is preferred. • Working
knowledge of FDA (21CFR 210, 211 & 820) and EU regulatory
requirements. • Experience in database maintenance/development.
Qualifications: • Master’s degree preferably in a science-related
field with four (4) years of related experience; OR • Bachelor’s
degree preferably in a science-related field with six (6) years of
related experience; OR • At least five (5) or more years of
experience in implementing and managing eQMS such as Veeva, MODA,
LIMS, Compliance Wire, TrackWise and/or related system. • A minimum
of four (4) years of leadership, with prior leadership experience
in eQMS or quality assurance strongly preferred. • At least four
(4) years of cGMP experience. Working Conditions & Physical
Requirements: The physical demands described here are
representative of those that must be met by an employee to
successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions. While performing
the duties of this job, the employee is regularly required to: •
Must be willing to work flexible hours. • Experience prolonged
standing, some bending, stooping, and stretching. • Ability to sit
for long periods to work on a computer. • Use hand-eye coordination
and manual dexterity sufficient to operate a keyboard, photocopier,
telephone, calculator, and other office equipment is required. •
Attendance is mandatory.
Keywords: , Pasadena , Quality Assurance eQMS Manager, Engineering , College Station, Texas
