Quality Assurance eQMS Manager
Quality Assurance eQMS Manager
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Position Overview
Summary: Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking an eQMS Manager to lead the configuration implementation analysis and maintenance of the electronic Quality Management Systems (eQMS). This role ensures compliance with cGMP and regulatory requirements while optimizing eQMS functionality and efficiency. The ideal candidate will have strong leadership skills technical expertise in eQMS systems and experience with quality system validation and compliance.
Company Overview
The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples 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 smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile 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
Key Responsibilities:
eQMS Administration & Compliance
- Oversee the installation configuration and maintenance of the eQMS.
- Ensure the eQMS remains compliant with regulatory standards and certifications including FDA 21 CFRAnnex 11 CFR part 11 and other regulation as applicable.
- Maintain controlled copies of quality documents and facilitate document retrieval during regulatory inspections.
- Execute document and change control processes to ensure standardization and accuracy.
- Identify and implement operational improvements to enhance eQMS efficiency.
System Support & Troubleshooting
- Provide troubleshooting support to end users and coordinate with system owners or vendors to resolve issues.
- Administer user accounts roles and system functions per global and local eQMS procedures.
- Work with IT and Quality personnel to ensure system compliance and security.
- Develop and execute validation scripts as needed for change control issues.
- Implement system workflows and reports to meet business needs.
- Support system validation by collaborating with local and global CSV teams reviewing validation documentation and conducting user acceptance testing (UAT) to ensure compliance and functionality.
- Develop review approve and deliver eQMS training materials to ensure effective system usage and compliance identifying and addressing training needs as required.
Leadership:
- Lead and mentor a team of eQMS professionals ensuring adherence to quality standards.
- Represent the eQMS group in crossfunctional meetings and global quality initiatives.
- Serve as the FDBT QA point of contact on the Global eQMS projects.
- Collaborate with management of other site functions to instill a Quality Culture by coaching on the application of CGMP Principles including the underlying rationale.
- Collaborate with Business Process Owners and system SMEs across departments to optimize eQMS functionality ensure compliance and drive continuous improvement.
- Manage team resources effectively ensuring strategic time management prioritization and adaptability to navigate project conflicts and shifting timelines.
- Conduct performance reviews for direct reports.
Audit and Regulatory Support:
- Review and approve changes to the validated state of systems through change control processes.
- Develop revise and manage eQMS SOPs deviations CAPAs change controls and Audit outcome.
- Support client due diligence quality audits and regulatory inspections.
- Perform other duties as assigned.
Required Skills & Abilities:
- Proven ability to lead teams implement process improvements and ensure regulatory compliance.
- Strong experience with eQMS solutions (e.g. Veeva MODA LIMS Compliance Wire TrackWise).
- Strong working knowledge of data privacy regulations in the US and Europe including GDPR.
- Expertise in FDA cGMP ISO 13485
- Experience with Quality Systems (Deviation OOS CAPA Change Control Audits etc..
- Strong organizational skills with excellent attention to detail and ability to manage multiple priorities.
- Strong problemsolving project management and decisionmaking skills.
- Proficiency in MS Office (Word Excel Outlook) and quality system software.
- Effective communication and collaboration skills across crossfunctional teams.
- Understanding of business continuity and risk management principles.
- Strong analytical and problemsolving skills.
- Certifications: Certified Quality Manager (CQM) Certified Quality Engineer (CQE) or similar certification preferred
Preferred Experience Skills & Abilities:
- Experience in developing cGMP training materials is preferred.
- Working knowledge of FDA 21CFR 210 211 & 820 and EU regulatory requirements.
- Experience in database maintenance/development.
Qualifications:
- Masters degree preferably in a sciencerelated field with four 4 years of related experience; OR
- Bachelors degree preferably in a sciencerelated field with six 6 years of related experience; OR
- At least five 5 or more years of experience in implementing and managing eQMS such as Veeva MODA LIMS Compliance Wire TrackWise and/or related system.
- A minimum of four 4 years of leadership with prior leadership experience in eQMS or quality assurance strongly preferred.
- At least four 4 years of cGMP experience.
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:
- Must be willing to work flexible hours.
- Experience prolonged standing some bending stooping and stretching.
- Ability to sit for long periods to work on a computer.
- Use handeye coordination and manual dexterity sufficient to operate a keyboard photocopier telephone calculator and other office equipment is required.
- Attendance is mandatory.
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.
Required Experience:
Manager
Employment Type
Unclear
