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Position Overview

The QA Supervisor Compliance – Change Controls/CAPAs/Deviations is tasked with leading the compliance team by emphasizing a People First Culture and principles while managing metrics and overseeing the closure of Change Controls and Quality Records (CAPA/Deviation). The Supervisor will be responsible for all related duties, ensuring adherence to Fujifilm's quality policies and site SOPs to maintain regulatory compliance.

Company Overview

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

Job Description

**Reports to** Associate Director/Director

**Work Location** College Station, TX

Primary Responsibilities:

+ Leadership

+ Mentors and provides leadership to the QA compliance team to ensure it is complying with local and global quality standards, regulatory requirements and partner commitments.

+ Develop, motivate and lead team towards achieving organizational and individual goals.

+ Work collaboratively with management and team members of other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.

+ Write performance reviews for direct reports.

+ Compliance Delivery

+ Demonstrates QA leadership and support to the organization in processing Quality Records, to be compliant and on-time.

+ Possesses understanding of production platforms utilized by the Texas site.

+ Possesses the ability to understand complex work and submit a strategy, to staff, for completing their work, as related to change Controls, CAPA, and deviations.

+ Has knowledge of global computer systems as related to impact of system changes.

+ Understands quality risk management principles.

+ Deliver metrics for understanding process performance and improvement opportunities.

+ New Business Growth

+ Support client due diligence and Quality audits as well as 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.

+ Provide cGMP guidance to other functions such as Manufacturing, Facilities, and QC.

+ Serve as system owner and SME to deliver training and guidance to end users.

+ Host system review boards with clear agendas, actions and minutes to facilitate on time closure metrics.

+ Utilize investigative techniques to assist deviation owners 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 deviation reports, corrective action/preventive action plans and change controls.

+ Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.

+ Perform other duties as assigned.

Qualifications:

+ Master’s degree ina science-related field with 3+ years of related experience;OR

+ Bachelor’s degree ina science-related field with 5+ years of related experience required.

+ 2+ years of prior leadership experience required.

+ 2+ years of cGMP experience required.

+ Certified Quality Auditor.

+ 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.

+ Role model for company core values of trust, delighting our customers, Gemba, and Genki.

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._

*LI-Onsite

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).

**Job Locations** _US-TX-College Station_

**Posted Date** _2 hours ago_ _(5/18/2025 8:39 PM)_

**_Requisition ID_** _2025-34587_

**_Category_** _Quality Assurance_

**_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_