Document Control Quality Assurance Manager - #249311

Summary : Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking a Document Control Manager to lead and oversee document control processes within the Quality Assurance function. This role ensures compliance with regulatory requirements, Fujifilm's quality policies, and site standard operating procedures (SOPs). The Document Control Manager will provide both strategic oversight and hands-on execution to maintain the integrity, accessibility, and organization of quality documentation, while leading a team of document control specialists.

Job Title: Quality Assurance - Manager, Document Control

Reports to: Sr. Director Quality & Compliance

Company Overview

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.

Job Description

Summary : Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking a Document Control Manager to lead and oversee document control processes within the Quality Assurance function. This role ensures compliance with regulatory requirements, Fujifilm's quality policies, and site standard operating procedures (SOPs). The Document Control Manager will provide both strategic oversight and hands-on execution to maintain the integrity, accessibility, and organization of quality documentation, while leading a team of document control specialists.

Key Responsibilities:

Document Control & Compliance

• Oversee the issuance, revision, approval, and archival of controlled documents, forms, and batch records in compliance with CGMP, FDA, and other relevant regulations.
• Ensure the accurate organization and secure storage of documents in both physical and electronic vaults.
• Manage document lifecycle processes, including creation, approval workflows, and version control.
• Maintain the integrity of document control procedures to ensure compliance with global quality policies.
  
  

Leadership & Continuous improvement:

• Mentor and provide leadership to the QA Document Control team, ensuring compliance with local and global quality standards, regulatory requirements, and partners commitments.
• Lead, mentor, and develop the QA Document Control team, fostering a culture of quality and compliance.
• Drive continuous improvements in document control workflows, identifying opportunities for increased efficiency and compliance.
• Establish and track key performance metrics for document control and compliance initiatives.
  
  

Audit and Regulatory Support:

• Support internal audits, regulatory inspections, and client due diligence by ensuring accurate and readily available documentation.
• Ensure document control activities align with business growth needs, from pre-clinical through commercial manufacturing.
• Perform other duties as assigned.
  
  

Required Skills & Abilities:

• Strong expertise in document control processes within a regulated industry (biotechnology, pharmaceuticals, or similar).
• Proven ability to lead teams, implement process improvements, and ensure regulatory compliance.
• Hands-on experience with eQMS platforms such as TrackWise, MasterControl, Compliance Wire and Veeva.
• In-depth knowledge of CGMP, FDA, and ISO regulations for document management.
• Strong organizational skills with excellent attention to detail and ability to manage multiple priorities.
• Effective communication and collaboration skills across cross-functional teams.
• Proficiency in Microsoft Excel, Word, and PowerPoint.
  
  

Qualifications:

• Master’s degree in a science-related field with three (3) years of related experience; OR
• Bachelor’s degree in a science-related field with five (5) years of related experience; OR
• Associate’s degree in a science-related field with seven (7) years of related experience.
• 5+ years of experience in document control within a regulated industry.
• A minimum of three (3) years of prior leadership experience.
• At least two (2) years of cGMP experience.
  
  

Preferred Qualifications:

• Prior leadership experience in a Quality Assurance role.
  
  

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:

• Experience prolonged standing, some bending, stooping, and stretching.
• Ability to sit for long periods to work on a computer.
• Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.
• 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.
• 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.
• Attendance is mandatory.
  
  

EEO Information

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.

ADA Information

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 ([email protected] or (979) 431-3500).