Senior Client-Facing Quality Programs Leader

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 140,000 - 190,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Senior Program Quality Manager to lead Quality Agreements from signature through program closure. You will liaison with clients, plan and monitor cross-functional programs, and ensure regulatory alignment with FDA and EU requirements.

Successful candidates will bring GMP-quality assurance, program management skills, and strong stakeholder collaboration to drive continuous improvement and customer satisfaction in a fast-paced biopharma

Qualifications

• Bachelor’s in Life Sciences or Engineering with 8+ years of experience or higher degrees with proportional experience.
• Experience in quality assurance in a GMP environment.
• Experience in developing and implementing regulatory strategies.
• Experience in customer relationship management or alliance management.

Responsibilities

• Act as primary Quality liaison and project team member between the client and FUJIFILM Biotechnologies, Holly Springs.
• Lead planning and execution of programs in alignment with Quality Agreements.
• Engage functional areas after the SOW to finalize quality agreement elements.
• Ensure quality agreements align with FDA, EU and other regulatory requirements.
• Coordinate and monitor contract elements of the Quality Agreement.
• Educate teams on key elements of the Quality Agreement.
• Represent Quality on project teams and steering committees as needed.
• Organize and facilitate Quality project teams with defined cadence.
• Provide meeting agendas and summaries; track decisions and actions; communicate status.
• Perform risk management across programs and escalate critical issues.

Skills

Client liaison

Quality management

Regulatory knowledge

Project management

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 in Holly Springs, NC, seeks a Senior Program Quality Manager to lead Quality Agreements from signature through program closure. You will liaison with clients, plan and monitor cross-functional programs, and ensure regulatory alignment with FDA and EU requirements.

Successful candidates will bring GMP-quality assurance, program management skills, and strong stakeholder collaboration to drive continuous improvement and customer satisfaction in a fast-paced biopharma