Quality Assurance - Risk Assessment Manager
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: March 14, 2023
Overview Follow Your Genki to FUJIFILM Diosynth Biotechnologies
(FDB) The work we do at FDB has never been more important-and we
are looking for talented candidates to join us. We are growing our
locations, our capabilities, and our teams, and looking for
passionate, mission-driven people like you who want to make a real
difference in people's 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 FDB call Genki.Summary: The Quality Assurance (QA) Risk
Management Manager position will be responsible for providing
leadership to the Texas site in ICH Q9 principles of Risk
Management. Ability to facilitate risk assessments, train future
facilitators, provide oversight and tracking of remediation
actions, and communicate to leadership on the status. External US
- Risk Management Delivery
- Support to the organization in leading the Risk Management
- Lead/facilitate Risk Management sessions
- Document and manage all Risk Assessments for the site
- Develop and issue weekly and monthly metric reporting
- Align Risk Management tools, ranking and filtering
- Manage Action item/Remediation activities
- 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.
- 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 assistance to other functions such as
Manufacturing, Facilities and QC.
- 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
- 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
- Understanding of biologic product life cycle as ICH Q8, Q9, and
- Experienced in FMEA, Fault Tree Analysis, Ishikawa Cause &
EffectWorking 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.Qualifications:
- Bachelor's degree in a science-related field and 10 years'
- Associates degree with 12 years' of related experience
- 6 years cGMP experience
- At least 4 year's management or supervisory experiencePreferred
- Degree in Biology, Chemistry or EngineeringWe 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 or call .
Keywords: FDBT - FUJIFILM Diosynth, College Station , Quality Assurance - Risk Assessment Manager, Executive , College Station, Texas
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