Senior Manufacturing Compliance Specialist

Position Overview

The Senior Compliance Specialist owns all manufacturing CAPAs, change controls and deviations. Leading all manufacturing deviation investigations through to completion.  Support all internal and external audits.  Work collaboratively with cross functional groups including Quality Assurance to support ‘on-time’ release and disposition of batches and other post-execution activities.

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

Essential Functions:

Responsible for the following activities within the Manufacturing Support Services function:

• Work collaboratively with staff and management of site functions to instill a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rational of those principles.   

Compliance

• Lead deviation, CAPA, and change control closure for Manufacturing

• Leads review of quality events and initiation of new deviations, as required
• Lead initiation of New Product Introduction change controls
• Lead Root Cause Analysis Investigations
• Lead Problem Analysis (PA) events
• Lead After Action Reviews (AAR)
• Lead the completion of Periodic Reviews
• Lead Internal and External Audit readiness, coordination, and response.
• Support Compliance Coordinators with the coordination of batch and formulation record review and corrections to executed records
• Support Compliance Coordinators with continuous improvement of batch related documentation
• Supports coordination of deviation workload within the Manufacturing Compliance Coordination group 
• Support the generation and maintenance of metrics around batch closure, including deviation, CAPA and change control status
• Support Compliance Coordinators to aid 100% on-time closure of all quality related investigations
• Provides training and support to the Compliance Coordinators
• Provides training and support to the Deviation Coordinators

Deviation Investigation

• Participate and support investigations for deviations and events.    
• Participate in investigations and assist in identification of root and/or contributing causes.      
• Ensures required Management and Quality approvals on final investigations while satisfying established due dates.  Facilitates corrective and preventive action agreement with stakeholders.  
• Support client due diligence and Quality audits as well as regulatory inspections.  
• Promptly notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.  

Equipment Compliance Coordination

• Is the Primary Point of Contact for any equipment related servicing and or Out of Service requests.
• Ensures all equipment is scheduled for routine maintenance and calibration and provide metrics for executed work.
• Work directly with the Facilities group to plan and support any on-site vendor support/maintenance activities including escorting on-site visitor requirements ensuring all visitors are registered for proper access on the equipment. 
• Ensure all equipment utilized on the floor for manufacturing execution is entered correctly into the Building Management System and has accurate and effective preventative maintenance activities. 
• Point of contact for client and regulatory inspection support with trends and metrics for all manufacturing equipment with respect to maintenance and life-cycle. 
• Maintains the schedule for plann