Quality Assurance Director

Responsibilities

• Lead and recruit the new Quality Assurance organizational structure for Singapore Operations facility start-up
• Plan, direct, and oversee QA Operations to facilitate patient supply needs
• Act as an escalation point for complex QA issues and manage them through to resolution
• Assess immediate and long-term risks to quality processes and implement pre-emptive solutions
• Drive transformation projects for new technology and digital change strategies within QA
• Manage relationships with regulatory bodies and maintain Global Quality network relationships
• Lead Quality Assurance initiatives and improvement programs for compliance and productivity
• Deliver and supervise budgets for Singapore QA
• Build, lead, and empower the quality team through coaching and development plans

Requirements

• Bachelor's or Master's degree in a science or technical field (Pharmacy, Biology, Chemistry)
• Considerable experience in supervisory or managerial roles within a sizeable pharmaceutical quality function
• Experience leading sophisticated projects involving resources, vendors, and budgets
• Experience with product launches, health authority inspections, and CMC requirements
• Experience driving large change initiatives through teams
• Ability to make decisions under pressure balancing patient safety, compliance, and supply
• Ability to influence senior internal and external stakeholders

Preferred Qualifications

• Track record in leadership of change management
• Experience managing managers
• Experience with biologics, synthetics, and Antibody Drug Conjugates (ADC) regulatory inspections
• Experience as a Responsible Person engaging with global regulatory bodies
• Multi-national and cross-cultural experience
• Experience with cross-functional and regional stakeholder management

About the Company

AstraZeneca is a forward-thinking BioPharmaceutical company dedicated to delivering life-changing medicines through cutting-edge science and digitalization.