Senior Quality Programs Lead (GMP & Regulatory)

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 120,000 - 170,000; Full time

Job summary

FUJIFILM Biotechnologies, Holly Springs seeks a Senior Program Quality Manager to oversee programs from Quality Agreement signature to closure. You will coordinate cross-functional teams, ensure regulatory alignment, and serve as the client liaison across quality activities.

The role involves risk management, audit support, and ongoing collaboration with the Senior Director, Global Program Quality to deliver compliant, high-quality programs in a fast-paced GMP environment.

Qualifications

• Experience in customer relationship management or alliance management.
• Experience in GMP quality assurance.
• Experience in developing and implementing regulatory strategies.

Responsibilities

• Acts as Primary Quality liaison between the client and FUJIFILM Biotechnologies, Holly Springs.
• Leads planning and execution of programs in alignment with Quality Agreements.
• After SOW draft, engages impacted functions to finalize quality elements.
• Ensures quality agreements reflect regulatory requirements (FDA, EU, other).
• Coordinates contract elements and risk management for Quality Agreements.
• Provides SME support for client audits with PQS team members.
• Organizes and leads quality project teams and maintains meeting cadence.
• Tracks quality performance and reports in Management Review.

Skills

Quality management

Project management

Regulatory affairs

Client audits

Cross-functional collaboration

English fluency

Education

Bachelor's in Life Sciences or Engineering

Master's in Life Sciences or Engineering

PhD in Life Sciences or Engineering

Job description

FUJIFILM Biotechnologies, Holly Springs seeks a Senior Program Quality Manager to oversee programs from Quality Agreement signature to closure. You will coordinate cross-functional teams, ensure regulatory alignment, and serve as the client liaison across quality activities.

The role involves risk management, audit support, and ongoing collaboration with the Senior Director, Global Program Quality to deliver compliant, high-quality programs in a fast-paced GMP environment.