Associate Director, Program Quality Management

Position Overview

The Associate Director (AD), Program Quality Management is responsible for building and sustaining the quality relationship with partners through transparent and trusting communications, working with Program Management and site SLTs to provide unprecedented delivery. This role is accountable for the quality aspects of customer programs from initial discussions through end of program review/close. The Associate Director, Program Quality Management works with customers to define quality requirements and governance for all programs, and agrees the process control strategy for the program, ensuring the right level of quality at the right time and demonstrates adaptability by ensuring processes meet regulatory requirements and support business aspirations (e.g. KojoX).

The Associate Director, Program Quality Management works effectively, independently and within a team framework, across all business areas, levels of the organization, and with clients to deliver high quality and ensures timely delivery of QA services. This role operates on both a strategic level with senior executives and facilitates operational elements in actual program execution.

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki.

Ready to shape the future of medicine? Let’s transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. 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:

• Partners with customers to agree the quality standards/governance/responsibilities for programs, documents and approves Quality Agreements and Statements of Work (SOW) and/or change orders, as necessary.
• Manages key product specific documentation, such as process control strategy, product specification and sample plan approvals ensuring the right quality at the right time and aligns the Quality Agreement/SOWs.
• Leads, plans, and executes programs in alignment with Quality Agreements.
• Acts as Quality point of contact for the Program Management team.
• Ensures timely and effective communication between the program client and site quality teams, stakeholders, and applicable functions as necessary with appropriate attendance at site tier/customer project/ customer steering meetings.
• Designs strong risk identification and management processes to highlight risk to programs, allowing solutions to be implemented without affecting the ability to deliver.
• Drives decisions and recommendations with SLT and/or global quality.
• Leads and coordinates client audits in partnership with the PQS team members providing strategic quality support.
• Leads Quality Management Review for customer programs ensuring a focus on continuous improvement, identifying trends and risks and agreeing actions with the customer/site.
• Ensures delivery of product specification files, annual product reviews, product quality management review and end of campaign reviews. Shares learnings through the organization and across programs.
• Provides global PQM representation to customers with programs at multiple sites by working across sites to deliver customer Quality governance.
• Partners with the Key Account Manager (KAM) organization to ensure regular feedback and input into relevant customer meetings.
• Organizes, leads, and facilitates Quality project teams (internal and external) and determines meeting…