Global QA Director: Inspection Readiness & Quality Strategy

FUJIFILM Electronic Materials (Europe) N.V.; North Carolina; In loco; USD 180.000 - 280.000; Tempo pieno

Descrizione del lavoro

FUJIFILM Biotechnologies in North Carolina seeks an Senior Director, QA to sit on the Site Leadership Team and Global QA Leadership Team, shaping site quality, executing global QA strategy, and embedding inspection readiness into daily operations. Lead Quality Operations, Systems, Training, and Supplier Qualification in a 24/7 GMP environment.

You will influence cross-functional teams across the US, UK, and Denmark, drive governance, and develop leaders to advance QA maturity and continuous

Competenze

• Master’s degree in Life Science, Pharmaceuticals, or a similar field with 13+ years of QA experience in biopharma or biotech.
• Bachelor’s degree in Science, Engineering, Life Science, Pharmaceuticals, or a similar field with 15+ years of QA experience in biopharma or biotech.
• 12+ years of people management, leadership, and team management experience.
• Prior experience in a GMP environment with FDA, EU, and MHRA regulations.
• Must be flexible to support a 24/7 manufacturing facility.

Mansioni

• Define and execute the site QA strategy aligned with corporate goals and regulatory standards; ensure readiness for regulatory inspections and customer audits.
• Lead and mentor a high‑performing QA organization across Quality Operations, Quality Systems, Quality Training, Supplier Qualification; collaborate with global QA.
• Guide the evolution of QA capabilities to meet current and emerging regulatory requirements.
• Oversee regulatory inspections and interactions; participate in customer visits and audits; ensure robust inspection management.
• Build and sustain resources and high-trust partnerships; identify cost-saving opportunities while maintaining compliance and quality.

Conoscenze

Leadership

Regulatory compliance

GMP experience

Executive presence

Strategic leadership

Formazione

Master’s degree in Life Science/Pharma

Bachelor’s degree in Science/Engineering

Descrizione del lavoro

FUJIFILM Biotechnologies in North Carolina seeks an Senior Director, QA to sit on the Site Leadership Team and Global QA Leadership Team, shaping site quality, executing global QA strategy, and embedding inspection readiness into daily operations. Lead Quality Operations, Systems, Training, and Supplier Qualification in a 24/7 GMP environment.

You will influence cross-functional teams across the US, UK, and Denmark, drive governance, and develop leaders to advance QA maturity and continuous