Associate Director, Global Program Quality

FUJIFILM Electronic Materials (Europe) N.V.; Holly Springs (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC seeks an Associate Director, Program Quality Management to lead quality governance for customer programs and ensure GMP-compliant delivery across sites. The role partners with Program Management and senior leadership to define quality requirements, manage risk, and drive continuous improvement while ensuring timely program close and regulatory alignment.

You will coordinate audits, approve quality documents, and mentor teams to uphold the highest

Qualifications

• Must have strong collaboration and communication skills across global teams.
• Experience in GMP environments and regulatory affairs knowledge.
• Proven ability to manage multiple programs and deliver on commitments.
• Experience driving risk management and continuous improvement.
• Familiarity with quality agreements, SOWs and audits.

Responsibilities

• Define quality governance for customer programs and SOWs.
• Lead, plan, and execute programs aligned with Quality Agreements.
• Serve as Quality point of contact for Program Management.
• Coordinate client and site audits and quality governance across sites.
• Drive continuous improvement by identifying trends and risks and taking action.
• Provide strategic quality support and mentorship to teams.

Skills

Collaboration

Communication

Organization

Attention to detail

Regulatory affairs

Stakeholder management

Regulatory intelligence

GMP

Leadership

Shift flexibility

Education

Bachelor's degree in Life Sciences, Engineering or related

Master's degree in Life Sciences, Engineering or related

D. in Life Sciences, Engineering or related

Job description

FUJIFILM Biotechnologies in Holly Springs, NC seeks an Associate Director, Program Quality Management to lead quality governance for customer programs and ensure GMP-compliant delivery across sites. The role partners with Program Management and senior leadership to define quality requirements, manage risk, and drive continuous improvement while ensuring timely program close and regulatory alignment.

You will coordinate audits, approve quality documents, and mentor teams to uphold the highest