Senior Director, Quality Assurance – Quality Control

About the role

The Senior Director of Quality Assurance for Quality Control will lead strategic and operational QA activities across analytical and manufacturing programs in a fast‑paced biotechnology environment. This role ensures compliance with global regulatory standards while supporting vaccine development and other critical drug substance projects.

Key responsibilities

• Provide strategic QA oversight for Quality Control activities, including analytical methods, validation, qualification, release testing, and in‑process testing.
• Review and approve GMP documentation such as specifications, certificates of analysis, validation reports, deviations, change controls, risk assessments, CAPAs, and analytical data packages.
• Partner with internal teams (QC, Process Development, Manufacturing, Regulatory) and external partners (CMOs, testing laboratories) to establish performance metrics and improve operational effectiveness.
• Drive resolution of quality issues, lead investigations of testing deviations and out‑of‑specification results.
• Support regulatory submissions and respond to health‑authority inquiries.
• Lead audit preparation and maintain inspection readiness across analytical programs.
• Develop and enhance GMP policies, procedures, and quality practices.
• Build a culture of quality excellence, accountability, and continuous improvement while leading a geographically distributed QA team.

Required profile

• Extensive senior‑level experience in quality assurance within biotechnology or pharmaceutical manufacturing.
• Deep knowledge of GMP regulations and vaccine development processes.
• Proven ability to lead cross‑functional teams and manage external partners.
• Strong track record of driving continuous improvement and regulatory compliance.

Required skills

• GMP compliance
• Analytical method validation
• Qualification and release testing
• In‑process testing
• Risk assessment
• CAPA management
• Regulatory submission support
• Audit preparation

What we offer

• Opportunity to influence global quality strategy for innovative healthcare solutions.
• Leadership of high‑performing, multidisciplinary teams.
• Collaborative environment with cutting‑edge biotechnology projects.