Director, QA Compliance - Audits & Inspections

Position Overview

The Director Quality Systems is responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FUJIFILM Biotechnologies in TX.  Responsibilities will include one or more PQS sub-system: Internal Audit, External (Customer) Audit, Health Authority Inspection, and Remediation.  Lead the assigned team to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders.  Ensure the site PQS sub-system is aligned with the harmonized global FUJIFILM Biotechnologies PQS, organizational goals and objectives, and areas of continuous improvement.

Company Overview

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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

Primary Responsibilities:

• Develop, implement, and maintain the risk-based PQS sub-systems to meet all CGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture.
• Establish governance and oversight processes to ensure the organization is continuously complying with site and global quality standards, regulatory requirements, and partner commitments.
• Lead the Quality Compliance team to deliver exceptional performance of each assigned sub-system.
  • Internal Audit.
  • External (Customer) Audit.
  • Health Auditory Inspection & Remediation.
• Liaise with internal and external stakeholders to achieve expected business outcomes.
• Partner with Quality Compliance to ensure the site is inspection ready at all times.
• Implement audit/inspection learnings within the site QMS; share learnings between FDB sites.
• Identify areas of risk and/or continuous improvement; escalate/communicate as appropriate.
• Provide expert guidance and interpretation on regulatory requirements.
• Recruit, hire, and manage the team in line with FDBT policies and practices.
• Ability to serve as deputy for Senior Director Quality Systems.
• Any other duties as assigned.

 

Qualifications:

• Bachelor’s degree with 10+ years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment; OR,
• Associate’s degree with 12+ years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment.
• 6+ years of experience in a supervisory or managerial role.
• 5+ years of experience working with biologics (vaccines, gene therapy, mAb, etc.) in a QA or QC role.
• Experience with biologics – vaccines, gene therapy, mAb, etc., preferred.
• Experience within CDMO preferred.
• Advanced Degree preferred.
• ASQ Certification preferred.
• Expert understanding of Pharmaceutical Quality Systems.
• 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 departmental objectives.
• Develop staff to maximize contributions to the team and the company.
• 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 substance, drug product, biologics, vaccine, and/or advanced therapy products.

 

Working Conditions & Physical Requirements:

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