QA Manager, QA Validation

Position Overview

The Quality Assurance (QA) Manager, QA Validation, will be responsible for the review and approval of commissioning/qualification/validation protocols, reports, and discrepancies. The Manager will handle all associated responsibilities in compliance with FUJIFILM Biotechnologies quality policies and site SOPs to ensure regulatory compliance.

Reports to Director, QA Compliance

Work Location College Station, TX

The work we do at FUJIFILM 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 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.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit:

Primary Responsibilities:

Leadership

• Provides direction to the validation team to ensure the organization is complying with local and global quality standards, regulatory requirements and partner commitments.
• Develop, motivate and lead direct reports 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 principles.

New Business Growth

• Support client due diligence and Quality audits as well as regulatory inspections.

Compliance

• Reviews and approves master plans, pre/post approval of qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
• Reviews and approves qualification and validation deviations and discrepancies, supports investigations and corrective actions.
• Participate in design reviews and have experience in reading P&’s and various engineering drawings.
• Coordinate with Validation, Metrology, Facilities, Engineering, on a daily basis to ensure any GMP protocols, requirements, etc. are completed in a timely manner.
• Utilize investigative techniques to determine root causes of discrepancies and proper corrective and preventative actions.
• Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• All other duties as assigned.

Qualifications:

• Master’s degree preferably in a science-related field with 5+ years of related experience, including qualification validation experience; OR,
• Bachelor’s degree in Biochemistry, Biology, Biotechnology, Microbiology or similar education and 7+ years of related experience, including qualification validation experience; OR,
• Associate’s degree in Biochemistry, Biology, Biotechnology, Microbiology or similar education and 9+ years of related experience, including qualification validation experience.
• 4+ years of supervisory experience required.
• 4+ years of cGMP experience required.
• Single Use and Process Validation preferred.
• Experience with qualification/validation of process equipment, clean utilities, automation, sterile filling, aseptic processing, facilities, HVAC, and new construction final qualification requirements of TOP’s for GMP facilities.
• Excellent written and oral communication skills.
• Excellent organizational, analytical, data review and report writing skills.
• Ability to set personal performance goals and provide input to…