The Quality Assurance (QA) Governance Manager is responsible for overseeing the implementation of quality initiatives, management of quality projects and site metrics, and administration of Quality Governance activities - including Quality Management Review, Daily Quality Review Board, Quality Metrics, and Quality Document Review Board.

Reports to                Sr. Director Quality Management System, Quality Assurance

Work Location         College Station, TX 

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what FUJIFILM Diosynth Biotechnologies call Genki. 

College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

Primary Responsibilities:

• Develop, implement, and maintain Quality Assurance governance procedures, policies and activities, including Quality Review Board, Quality Management Review, Quality Metrics, and Quality Document Review board.
• Collaborate with cross functional teams and global QA to establish Quality Benchmarks and Performance KPIs.
• Analyze quality data and metrics to identify trends, root causes, and areas for improvement.

• Manage communication and reporting related to Quality Assurance governance activities.

• Manage the QA team by providing guidance, training, and mentoring to enhance efficiency and performance.
• Oversee and manage quality action plan and quality improvement projects.
• Create Site Dashboards using Excel and Tableau.
• Create and sustain internal Quality policies, procedures, and reports as needed.
• Identify process and Quality System improvement opportunities.
• Review and/or approve basic and technical documentation, such as, Deviation Reports, Corrective Action/Preventive Action Plans, Technical data review and approval, Standard Operating Procedures, Facilities/Engineering Work Orders, and Logbooks.
• Support departments with problem solving, process improvements, Root Cause Analysis, CAPA planning, and Effectiveness Checks.
• Provide guidance for the compliance of the QA department to national and international standards and regulations.
• All other duties as assigned.

Qualifications:

• Master’s Degree and 5+ years of Pharmaceutical or other regulated Industry experience.
• Bachelor’s Degree and 7+ years of Pharmaceutical or other regulated Industry experience.
• Degree in Biology or Chemistry preferred.
• Experience with Alteryx Designer and Tableau Creator.
• Project Management experience
• Ability to lead a team and set performance goals to achieve departmental objectives.
• Excellent written and oral communication skills.
• Excellent organizational, analytical, data review and report writing skills.
• Proficient in Microsoft Excel, Word, and PowerPoint.
• All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products.
• 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 must regularly:

• Experience prolonged standing, some bending, stooping, and stretching.
• 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.
• Attendance is mandatory.

Join us!  FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential.  We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBTHR@fujifilm.com or (979) 431-3500).