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

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FUJIFILM Diosynth Biotechnologies call Genki. 

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

Key Responsibilities:

eQMS Administration & Compliance

• • • • Oversee 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 troubleshooting support to end users and coordinate with system owners or vendors to resolve issues.
      • Administer user accounts, roles, and system functions per global and local eQMS procedures.
      • Work with IT and Quality personnel to ensure system compliance and security.
      • Develop and execute validation scripts as needed for change control issues.
      • Implement system workflows and reports to meet business needs.
      • 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.
      • 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.

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).