Quality Assurance - Manager, Compliance and Change Control
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: November 22, 2021
Overview Summary:-- The Quality Assurance - Manager Compliance
and Change Control, will be responsible for the leading the
compliance team with the management, metrics, and closure of Change
Controls.-- The Manager will handle all associated responsibilities
in compliance with Fujifilm quality policies and site SOPs to
ensure regulatory compliance.-- External US Essential
- 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 of other site functions to
instill a ---Quality Culture--- by coaching in the application of
GMP Principles including the underlying rational of those
- Write performance reviews for direct reports.Compliance
- QA leadership and support to the organization in conducting
Change Controls, to be compliant and on-time
- Deliver metrics for understanding process performance and
- New Business Growth
- Support client due diligence and Quality audits as well as
- 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.
- Utilize investigative techniques to assist deviation owners to
determine root causes of deviations and proper corrective and
- 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
- All other duties as assigned.Required Skills & Abilities:
- Excellent written and oral communication skills.
- Excellent organizational, analytical, data review and report
- Ability to set personal performance goals and provide input to
- Develop staff to maximize contributions to the team and the
- 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
- Experience prolonged standing, some bending, stooping, and
- 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.
- Master---s degree preferably in a science-related field with
four (4) years of related experience, including qualification
validation experience, and two (2) years of supervisory experience:
- Bachelor---s degree preferably in a science-related field with
six (6) years of related experience, and two (2) years of
- At least 4 years of cGMP experience.Preferred Qualifications:
- Certified Quality Auditor
- Degree in Biology, Chemistry or Engineering
- --We are an equal opportunity and affirmative action
employer.-- All qualified applicants will receive consideration
without regard to race, color, national origin, sex, gender
identity, sexual orientation, religion, disability, protected
veteran status or any other characteristic protected by applicable
federal, state or local law.--If an accommodation to the
application process is needed, please e-mail FDBTHR@fujifilm.com or
Keywords: FDBT - FUJIFILM Diosynth, College Station , Quality Assurance - Manager, Compliance and Change Control, Executive , College Station, Texas
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