Quality Assurance (QA) Validation, Associate Director - FujiFilm Diosynth Biotechnologies : Job Details

Quality Assurance (QA) Validation, Associate Director

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Quality Assurance (QA) Validation, Associate Director

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Summary:

Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking Quality Assurance (QA) Validation - Associate Director to oversee the review and approval of commissioning, qualification, and validation protocols, reports, and discrepancies. This role will ensure compliance with FUJIFILM Diosynth Biotechnologies' quality policies, site SOPs, and regulatory requirements while providing strategic leadership to the validation team.

Job Title: Quality Assurance (QA) Validation, Associate Director

Reports to: Director, Quality Assurance Compliance

Company Overview

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.

Job Description

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.

Seniority level

• Seniority levelDirector

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Tuition assistance

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