Associate Director, Quality Programs & Delivery

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 180,000 - 230,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks an Associate Director, Program Quality Management to build and sustain a transparent quality relationship with partners, guiding program quality from initial discussions through end-of-program review and close.

The role collaborates with Program Management, site SLTs and customers to define governance, drive risk management, and ensure regulatory compliance to support business goals and timely delivery of QA services across programs.

Qualifications

• Bachelor’s degree with 11+ years of experience; or Master’s with 9+ years; or PhD with 7+ years in related fields.
• Experience in customer relationship management or alliance management.
• Experience in quality assurance in a GMP environment.

Responsibilities

• Partners with customers to define quality standards/governance/responsibilities for programs, documents and approves Quality Agreements and 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 and stakeholders.

Skills

Regulatory affairs

Quality management

Stakeholder management

Program leadership

Communication

GMP compliance

Education

Bachelor’s degree in Life Sciences, Engineering or related field

Master’s degree in Life Sciences, Engineering or related field

Ph.D. in Life Sciences, Engineering or related field

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, seeks an Associate Director, Program Quality Management to build and sustain a transparent quality relationship with partners, guiding program quality from initial discussions through end-of-program review and close.

The role collaborates with Program Management, site SLTs and customers to define governance, drive risk management, and ensure regulatory compliance to support business goals and timely delivery of QA services across programs.