Associate Director, Pharmaceutical Quality Assurance

CSL Behring seeks an Associate Director, Project Quality to lead quality oversight for complex drug development and manufacturing projects. In this role, you will define and implement project quality strategies, ensure compliance with GxP and global regulatory standards, and drive risk management and continuous improvement. You will partner with cross-functional teams across R&D, clinical, manufacturing, and regulatory to embed quality by design, lead audits and inspections, and resolve critical quality issues. This position requires strong leadership, stakeholder management, and deep experience in pharmaceutical or biotech quality systems.

Responsibilities

• Lead project quality strategy and planning across complex biotech programs
• Ensure compliance with Gx
• P and global regulatory requirements
• Oversee quality risk management and mitigation activities
• Collaborate with R&D, clinical, manufacturing, and regulatory stakeholders
• Lead and support internal and external audits and inspections
• Monitor quality metrics and drive continuous improvement initiatives
• Review and approve key quality and project documentation
• Provide quality leadership, training, and mentorship to project teams
• Escalate and resolve critical quality issues impacting project deliverables

Required Skills

• Gx
• P compliance
• Quality management systems (QMS)
• Risk management (FMEA, risk registers)
• Regulatory knowledge (FDA, EMA, ICH)
• Audit and inspection management
• Project management
• Data and quality metrics analysis
• Deviation/CAPA management
• Document control and validation practices
• Cross-functional stakeholder management