Summary:   FUJIFILM Biotechnologies Texas (FDBT) is seeking a Senior eQMS Specialist to support the configuration, implementation, analysis, and maintenance of the electronic Quality Management Systems (eQMS). This role ensures system compliance with cGMP and regulatory requirements while optimizing eQMS functionality and efficiency. The ideal candidate will have strong technical expertise in eQMS systems and experience with quality system validation and compliance.

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.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Reports to:   Quality Assurance eQMS Manager

Location:       College Station, TX

Key Responsibilities:

eQMS Administration & Compliance

• Support the installation, configuration, and maintenance of the eQMS.
• 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.
• Maintain controlled copies of quality documents and facilitate document retrieval during regulatory inspections.
• Execute document and change control processes to ensure standardization and accuracy.
• Identify and implement operational improvements to enhance eQMS efficiency.

System Support & Troubleshooting

• Provide end-user support and collaborate with system owners or vendors to resolve technical issues.
• Administer user accounts, roles, and permissions in line with global and local procedures.
• Work alongside IT and Quality teams to ensure system security and compliance.
• Assist in developing and executing validation scripts for system changes.
• Support the implementation of system workflows and reports to meet operational needs.
• Participate in system validation activities, including reviewing documentation and conducting User Acceptance Testing (UAT).
• Contribute to the development and delivery of eQMS training materials to ensure effective system use and compliance.

Collaboration & Continuous Improvement:

• Represent the eQMS group in cross-functional meetings and global quality initiatives as needed and expected to step in as a representative when leadership is not present.
• Represent FDBT QA on the Global eQMS project as assigned.
• Collaborate with Business Process Owners and system SMEs to optimize eQMS functionality, ensure compliance, and drive continuous improvement.
• Promote a “Quality Culture” by supporting CGMP principles and best practices across departments.

Audit and Regulatory Support:

• Support change control related to assigned validated systems. 
• Assist in developing, updating, and maintaining related assigned eQMS SOPs, deviations, CAPAs, change controls and Audit outcome.
• Participate in client due diligence, quality audits, and regulatory inspections.
• Perform other duties as assigned.

Required Skills & Abilities:

• Proven ability to lead projects, 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.

Minimum Qualifications:

• Master’s degree preferably in a science-related field with 3+ years of related experience; OR
• Bachelor’s degree preferably in a science-related field with 5+ years of related experience; OR
• Associate’s degree preferably in a science-related field with 7+ years of related experience.
• 3+ years of experience in implementing and managing eQMS such Veeva, MODA, LIMS, Compliance Wire, or Track Wise.
• 3+ years of cGMP experience.

Preferred Experience, Skills & Abilities:

• Experience in developing cGMP training materials.
• Working knowledge of FDA (21CFR 210, 211 & 820) and EU regulatory requirements.
• Experience in database maintenance/development.
• Certifications such as Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or similar are a plus.

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.

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBTHR@fujifilm.com or (979) 431-3500).