The Quality Assurance (QA) Manager of Audit & Inspection will be responsible for the hosting and managing client audits, regulatory inspections, internal audits, and supplier assurance.  The Manager will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance. 

Reports to                Director, Quality Assurance Compliance

Work Location         College Station, TX 

The work we do at FUJIFILM 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 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

Essential Functions:

Leadership

• Mentors and provides direction to the QA compliance organization to ensure organization is complying with local and global quality standards, regulatory requirements and partner commitments.
• Develop, motivate and lead direct reports towards achieving organizational and individual goals.
• Work collaboratively with management of other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.

Compliance Delivery

• QA leadership and support to the organization in conducting audits and hosting audits/inspections.

New Business Growth

• Support client due diligence and Quality audits as well as regulatory inspections.
• Work with Quality management to implement quality systems that will enable cGMP manufacturing of pre-clinical to commercial products.

Compliance

• Responsible for managing and reporting all aspects of a fully functional GxP-QA audit program for clinical and commercial CDMO.
• Manage the external and internal Audit Programs to assure that all are in an acceptable state of compliance.
• Responsible for audit preparations, conducting internal audits, hosting client audits, developing and coordinating responses to client audits, regulatory inspections, and to ensure supporting documentation, tracking and verification of CAPA commitment implementation.
• Provide and manage metrics and the implementation tracking of corrective and preventive actions in follow-up to audits and inspections.
• Support Global Supplier Assurance - work with the global team to participate and represent Texas Site in supporting joint audits.
• All other duties as assigned.

Required Skills & Abilities:

• Master’s degree with 5+ years’ industry experience in a GMP/GxP, or a comparable federally regulated environment.
• Bachelor’s degree 7+ years’ industry experience in a GMP/GxP, or a comparable federally regulated environment.
• 4+ years of experience in supervisory or managerial role.
• Experience with direct dealings with the FDA, MHRA and other European or world-wide regulatory agencies.
• Certified Quality Auditor preferred.
• Degree in Biology, Chemistry or Engineering preferred.
• Excellent written and oral communication skills.
• Excellent organizational, analytical, data review and report writing skills.
• Ability to set personal performance goals and provide input to departmental objectives.
• Develop staff to maximize contributions to the team and the company.
• Ability to multitask and easily prioritize work.
• Ability to work independently with little supervision.
• Proficient in Microsoft Excel, Word and PowerPoint.
• All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.

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.

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.

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).