Quality Assurance (QA) Validation, Associate Director
Location: College Station
Posted on: June 23, 2025
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Job Description:
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. Essential Functions: Leadership •
Develop, implement and maintain QA oversight activities to meet all
GMP guidance and direction to the validation team to ensure
adherence to local and global quality standards, regulatory
requirements and partner commitments. • Maintain an operational
tier structure to ensure the site is continuously complying with
standard operating procedures, processes, regulatory requirements,
and partner commitments. • Identify and implement best practices to
improve right first time (RFT) execution. • Develop, mentor,
motivate and lead direct reports to achieve individual and
organizational objectives. • Collaborate with cross functional
teams and management to instill a “Quality Culture” by coaching
personnel on GMP principles and their applications. QA Validation
and Compliance • Review and approve master validation plans,
qualification/validation protocols, summary reports, and associated
data to ensure regulatory and SOP compliance. • Identify areas of
risk and/or continuous improvement; escalate/communicate as
appropriate. • Oversee and approve validation deviations and
discrepancies, supporting investigations and corrective actions,
and participate in design reviews, assess P&IDs, and review
engineering drawings for compliance. • Collaborate with Validation,
Metrology, Facilities, and Engineering teams to ensure GMP
protocols and requirements are met in a timely manner. New Business
Growth • Lead the effort to support client due diligence, quality
audits, and regulatory inspections to ensure compliance with
industry and company standards. • Perform other duties as assigned.
Required Skills & Abilities: • Proven ability to motivate and lead
teams instilling our Company philosophy, culture, and People
Fundamentals. • Experience in qualification/validation of process
equipment, clean utilities, automation, sterile filling, aseptic
processing, HVAC systems, and new GMP facility construction. •
Strong understanding of cGMP regulations for the production of
drug, biologics, or vaccine products. • Excellent written and
verbal communication skills, with strong organizational and
analytical abilities • Excellent organizational, analytical, data
review and report writing skills. • Ability to prioritize tasks,
multitask effectively, and work independently with minimal
supervision • Develop staff to maximize contributions to the team
and the company. • Proficiency in Microsoft Excel, Word and
PowerPoint. Qualifications : • Bachelor’s degree with eight (8)
years of relevant experience in a heavily regulated environment
such as pharmaceutical, biotechnology, or supporting a CDMO
environment; OR • Associate’s degree with ten (10) years of
relevant experience in a heavily regulated environment such as
pharmaceutical, biotechnology, or supporting a CDMO environment. •
At least four (4) years of experience in a leadership or prior
supervisory/managerial role. • A minimum of five (5) years of
experience working with biologics (vaccines, gene therapy, mAb,
etc.) in a QA or QC role. Preferred Qualifications: • Degree in
Biology, Chemistry or Engineering. • Single Use and Process
Validation a plus. • Previous leadership experience in Quality
Control or Quality Assurance. 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: •
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.
Keywords: , Austin , Quality Assurance (QA) Validation, Associate Director, Science, Research & Development , College Station, Texas
