The Sr. Program Quality Manager is responsible for programs from the point of Quality Agreement signature through program closure. This role ensures Fujifilm Biotechnologies, Morrisville (FDBU) provides services in alignment with our contracted commitment to clients and our company vision/mission (strategy and compliance). This role is the primary client liaison representing FDBU Quality. The Sr. Program Quality Manager handles an average load of 1-3 programs and receives coaching & guidance from the Senior Director, Global Program Quality.

At FUJIFILM Diosynth Biotechnologies U.S.A., we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Diosynth Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.

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

Major Accountabilities 

• Acts as Primary Quality liaison and project team member between the client and FDBU
• Leads the planning and execution of programs in alignment with Quality Agreements (vision, mission, strategy-goals-objectives)
• After the Sales Team completes the initial draft Scope of Work (SOW), engages impacted functional areas for inputs to ensure the quality agreement elements are complete and realistic
• Ensures that the quality agreement is organized based on segments of work and regulatory requirements including FDA, EU, and other regulatory agencies
• Coordinates and monitors completion of the contract elements of the Quality Agreement
• Understands the approach and details of the SOW and communicates to the Project PM any work requested beyond the quality agreement/contract that is covered by change orders
• Acts as Subject Matter Expert (SME) and provides strategic support for client audits in partnership with the PQS team members
• Participates in cross-functional Program Kickoffs (Internal & Client)
• Educates the impacted organization about the key elements/deliverables of the Quality Agreement
• Represents Quality on the project team & steering committee membership as needed
• Organizes, leads, and facilitates Quality project teams (internal and external) and determines meeting cadence for each program
• Provides a standard agenda and meeting summaries such as discussion points, decisions, action-risk log. Implements a project team meeting cadence which enables appropriate internal discussions and client engagement/communication
• Assigns and tracks specific functional accountabilities
• Actively conducts risk management within and across programs. Escalates unresolved issues-risks-decisions to functional leaders and/or tier process as appropriate to ensure that SLT knows the impact and potential intervention needed for resolution of potential Quality issues
• Tracks and reports programs quality performance through periodic Management Review
• Provides timely responses to clients including but not limited to communications involving deviations, change management, product disposition, and all other quality agreement deliverables
• Performs Quality approval of high-level documents, including, process control strategy, product specification, and PPQ protocols/reports
• Performs other duties, as assigned

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 (HR_FDBU@fujifilm.com).