Senior Program Quality Lead: Client Liaison & Compliance

FUJIFILM Electronic Materials (Europe) N.V.; Holly Springs (NC); On-site; USD 130,000 - 170,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs seeks a Senior Program Quality Manager to drive quality programs from contract signature to closure, ensuring alignment with client commitments and company strategy.

You will liaise with clients, lead cross-functional teams, manage quality agreements across regulatory requirements, and support audits, change control, and risk management in a GMP environment. Fluency in English is required, with the ability to support 24/7 operations.

Qualifications

• Bachelor’s degree with 8+ years of applicable industry experience.
• Advanced knowledge of GMP and regulatory strategies.
• Experience in customer relationship or alliance management.

Responsibilities

• Acts as Primary Quality liaison and project team member between client and FUJIFILM Biotechnologies, Holly Springs.
• Leads planning and execution of programs in line with Quality Agreements.
• Ensures quality agreements meet regulatory requirements (FDA, EU, etc.).
• Manages risk, change control, and client communications throughout the program.
• Supports audits and provides SME guidance with PQS team.
• Organizes and leads cross-functional program Kickoffs and Steering Committees.

Skills

Project Management

Regulatory affairs

GMP knowledge

Quality Assurance

Risk management

Cross-functional collaboration

Education

Bachelor’s in Life Sciences or Engineering or equivalent

Master’s in Life Sciences or Engineering

PhD in Life Sciences or Engineering

Job description

FUJIFILM Biotechnologies in Holly Springs seeks a Senior Program Quality Manager to drive quality programs from contract signature to closure, ensuring alignment with client commitments and company strategy.

You will liaise with clients, lead cross-functional teams, manage quality agreements across regulatory requirements, and support audits, change control, and risk management in a GMP environment. Fluency in English is required, with the ability to support 24/7 operations.