Quality Assurance Director

Are you ready to lead and innovate in the realm of Quality Assurance Singapore Operations will play a key role in our ambition to redefine cancer care and deliver life-changing medicines to patients around the world. As the Director of Site Quality Assurance Operations, you will oversee multiple facilities for end-to-end manufacturing and control within our new Singapore campus, ensuring excellence in QA across raw materials, biologics, synthetic and sterile filling and warehousing processes being built to support our strong new product pipeline.

This pivotal role involves working on diversified tasks, leading high-level projects, developing strategic plans, and defining innovative solutions to navigate complex business challenges. You are proactive, manage risks and act with integrity to protect our patients and business. With a comprehensive understanding of global processes, you will provide strategic direction and inspire other managers and individuals to grow within the organization!

Accountabilities:

• Lead, create, and staff the new Quality Assurance organizational structure supporting Singapore Operations facility start-up and subsequent clinical and commercial manufacturing.
• Plan, direct, and oversee QA Operations to facilitate delivery of the supply needs of patients.
• Act as an escalation point for complex issues within QA, managing issues through to resolution.
• Determine the talent, materials, equipment, and services required for long-term delivery targets, ensuring adequate resourcing and development of capabilities.
• Assess immediate and long-term risks to quality processes and workflows, implementing pre-emptive solutions through cross-functional engagement.
• Drive transformation projects for new technology and digital change strategies within QA.
• Direct future-focused skill-development interventions through cross-functional, regional, global and external partnerships.
• Explore, identify, evaluate, and leverage opportunities for technology and exemplary practice adoption within the site.
• Manage relationships with regulatory bodies as needed, resolving any issues raised.
• Maintain AstraZeneca Global Quality network relationships on behalf of QA Operations.
• Proactively identify risks and opportunities using appropriate risk management techniques balanced with compliance, quality principles, and regulatory requirements.
• Lead Quality Assurance initiatives and improvement programs aimed at ensuring compliance, continuous improvement, productivity, profitability, and safety.
• Deliver and supervise budgets for Singapore QA.
• Build, lead, and empower the quality team to achieve aspirational goals.
• Develop professional and leadership capabilities of quality professionals and managers through coaching, delegation, and development plans.

EssentialSkills/Experience:

• Bachelor's/Master's degree in a science/technical field such as Pharmacy, Biology, Chemistry.
• Considerable experience in supervisory/managerial roles within leading a sizeable quality function in the Pharmaceutical Industry.
• Experience leading sophisticated projects/operations in terms of resources, vendors, and budgets.
• Experience with product launches, health authority inspections, CMC requirements and global commercial product requirements.
• Experience driving large change initiatives through teams.
• Proven ability to deliver and work in a fast-paced environment across multiple technical functions.
• Demonstrated ability to make decisions under pressure that sufficiently balance patient safety, compliance and supply.
• Ability to influence senior stakeholders, both internally and externally.

DesirableSkills/Experience:

• Demonstrated track record in leadership of change management in a positive and non-disruptive manner to the company's values.
• Experience managing managers.
• Experience with biologics, synthetics, and Antibody Drug Conjugates (ADC) regulatory inspections.
• Experience being a Responsible Person.
• Experience engaging with global regulatory bodies.
• Proven track record of attracting and developing talent.
• Multi-national and cross-cultural experience.
• Experience with cross-functional, regional, and external stakeholder management.

At AstraZeneca, we take Quality seriously. We are always innovating, and trialing modern technologies and automation to improve reliability and excellence in our processes. We are proactive, science-based, and solutions-oriented. It's our ambition to go far that keeps pushing us forward.