Associate Director, QC Compliance

Location: College Station
Posted on: June 23, 2025

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. Primary Responsibilities: Compliance with Quality Systems: • Lead efforts to ensure that Quality Control processes are in full compliance with established quality systems and GMP regulations. • Collaborate with the Quality Assurance team to align QC practices with overarching quality standards without duplicating roles in QA. Quality Standards and Process Management: • Oversee the lifecycle management of Quality Control Standard Operating Procedures (SOPs), ensuring they meet quality requirements and are consistently followed. • Develop and maintain effective training programs to enhance QC staff competence in compliance with quality systems. Training Coordination and Effectiveness: • Organize and oversee training activities, ensuring all QC personnel are knowledgeable and proficient in QC procedures and regulations. • Evaluate the effectiveness of training programs, making adjustments to optimize learning outcomes and compliance adherence. Change Control Management: • Manage change control activities related to QC methods, equipment, and processes to maintain continuous compliance. • Ensure thorough documentation and implementation of changes to uphold product quality and regulatory standards. Leadership: • Manage and mentor a team of QC Compliance professionals, fostering a positive and collaborative work environment. Deviation Management and Trending: • Lead deviation investigations within QC, ensuring robust root cause analysis (RCA) and application of corrective and preventive actions (CAPA). • Conduct trend analysis on deviations to identify areas for process improvement and enhance compliance. GMP Documentation and Data Integrity: • Ensure meticulous compliance with Good Documentation Practices (GDP) and data integrity throughout QC operations. • Conduct holistic reviews of testing, batch records, and stability studies to identify trends and rectify discrepancies. Data Trending and Analysis: • Direct data trending and analysis efforts to provide valuable insights into QC performance, helping drive improvements in quality and stability. • Collaborate with QC teams to implement data-backed improvements that support compliance and quality enhancement. • All other duties as assigned. Qualifications: • Bachelor’s degree in Chemistry, Biology, or other scientific discipline and 8 years of experience in Quality Control/Quality Assurance within the pharmaceutical/biopharmaceutical industry, focused on compliance and quality systems. • 5 years of leadership experience required. • Experience with data integrity and compliance as related to quality control labs preferred. • Advanced degree preferred. • Strong understanding of GMP regulations and QC process management. • Demonstrated leadership abilities. • Demonstrated expertise in deviation management, RCA, CAPA, change control, and data integrity. • Strong leadership skills with excellent project management capabilities. • Highly analytical with strong problem-solving skills and a focus on compliance. • Excellent communication and interpersonal skills to work effectively across departments. • Role model for company core values of trust, delighting our customers, Gemba, and Genki. 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 as needed. • Onsite attendance is required.

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