QA Supervisor, Compliance â Change Controls/CAPAs/Deviations

Fujifilm

Posted on : 20-05-2025

Employer Active

1 Vacancy

Job Alert

You will be updated with latest job alerts via email

Valid email field required

Send jobs

Send me jobs like this

Job Alert

You will be updated with latest job alerts via email

Valid email field required

Send jobs

Job Location

College Station, TX - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 20-05-2025

Job Description

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 Fujifilms quality policies and site SOPs to maintain regulatory compliance.

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies Texas has never been more importantand we are looking for passionate missiondriven people like you who want to make a real difference in peoples 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 youre ready to help transform the future of medicine join FUJIFILM Diosynth Biotechnologies. We offer a flexible work environment and were proud to cultivate a culture that will fuel your passion energy and drivewhat we call Genki.

Our stateoftheart biomanufacturing facility is located in in College Station Texas which combines a smalltown feel with vibrant culture topnotch schools and close proximity to big city life. Nestled between major hubs its a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70000 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: 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 ontime.
- 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 phaseappropriate quality systems that will enable cGMP manufacturing of preclinical 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:

Masters degree in a sciencerelated field with 3 years of related experience; OR
Bachelors degree in a sciencerelated 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 handeye 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 offshift 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 viaemail 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.

*LIOnsite

EEO Information

Fujifilm is committedto 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 preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ( or (979)).

Required Experience:

Manager

Employment Type

Unclear

Company Industry

Key Skills

Apply Now

About Company

Fujifilm

Report This Job

Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.

Start Now

Dr.Job AutoApply

3X your job search with AutoApply's AI for faster dream job results.

QA Supervisor, Compliance â Change Controls/CAPAs/Deviations

Fujifilm

Job Description

Position Overview

Company Overview

EEO Information

ADA Information

Employment Type

Company Industry

Key Skills

About Company

Similar Jobs

Supply Chain Supervisor

Legal & Compliance Officer

Housekeeping Supervisor

SUPERVISOR DE MANTENIMIENTO

Project Controls â Risk - Defence

Project Controls â Risk - Defence

Change Manager

Organizational Change Managemer

QA Supervisor, Compliance â Change Controls/CAPAs/Deviations

Fujifilm

Job Description

Position Overview

Company Overview

Employment Type

Company Industry

Key Skills

About Company

Similar Jobs

QA Supervisor, Compliance â Change Controls/CAPAs/Deviations