The Quality Assurance (QA) Manager of Operations will be responsible for the overall performance of one or more QA Operations groups.  The Manager will handle all associated responsibilities in compliance with FUJIFILM quality policies and site SOPs to ensure regulatory compliance. 

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

Reports to                Director, QA Operations

Work Location         College Station, TX 

Primary Responsibilities:

Leadership

• Mentors and provides direction to the QA Operations organization to ensure the 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.

Operational Delivery

• Delivery of QA support to the compliant and on-time introduction of GMP programs into manufacturing and disposition of Drug Substance/Product.
• Delivery of guidance and on-the-floor support to maintain compliance of Facility with international standards and regulations for continued GMP manufacturing.

New Business Growth

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

Compliance

• Ensure self, and team, have no overdue training, or site actions. Support other QA teams and other functions in completion of site actions.
• Continuously improve the processes specified in Standard Operating Procedures and Work Instructions operated by self and direct reports whilst still ensuring the operations meet all current regulatory requirements.
• Provide cGMP guidance to other functions such as Manufacturing, Facilities and QC.
• Utilize investigative techniques to determine root causes of deviations and proper corrective and preventative actions.
• Review and/or approve basic and technical documentation to include, but not limited to:
  • Standard Operating Procedures
  • Batch Production Records (completed and approval)
  • Commissioning, qualification and validation protocols and reports
  • Deviation Reports, Corrective Action/Preventive Action Plans and Change Controls
  • QC data review and approval
  • Drug Substance/Product Reports
  • Client regulatory submissions
• Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Perform other duties and projects as assigned and required.

Qualifications:

• Master’s degree preferably in a science-related field with 7+ years industry experience in a GMP/GxP, or a comparable federally regulated environment of related experience; OR,
• Bachelor’s degree preferably in a science-related field with 9+ years industry experience in a GMP/GxP, or a comparable federally regulated environment; OR,
• Associate’s degree preferably in a science-related field with 9+ years industry experience in a GMP/GxP, or a comparable federally regulated environment; OR,
• High School Diploma or equivalent with 11+ years industry experience in a GMP/GxP, or a comparable federally regulated environment.
• 5+ years of experience in a supervisory or managerial role required.
• Certified Quality Auditor preferred.
• Degree in Biology, Chemistry 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.
• Role model for company core values of trust, delighting our customers, and Gemba.

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 essential functions.  While performing the duties of this job, the employee is required on a regular basis 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).