PQS Associate Director - Quality Systems

About the role

AstraZeneca is looking for an Associate Director for its Pharmaceutical Quality System (PQS) at Wuxi Supply Point. The role establishes and sustains a proactive, professional culture of regulatory compliance that meets regulatory requirements, adds value and gives the business a competitive advantage. It also contributes to the QA function's development and improvement of the quality management system.

Key responsibilities

• Coordinate and oversee functional quality and compliance across departments, and lead and support quality continuous improvement projects.
• Lead and coordinate key quality systems such as GMP training, document management, QAA management, change control, quality risk management, self-inspection, complaint management and management review, using Lean tools.
• Support non-PET business areas such as QC and E&SHE with quality oversight, including change control, complex quality issues and validation.
• Monitor external regulations, advise on compliance, and act as subject matter expert for QA teams, investigations and 3PS and CMO matters.
• Coordinate and lead internal and external GMP inspections, and localize the global quality management system to fit local processes.
• Maintain and improve PQS procedures and electronic systems, and provide quality system training and coaching.
• Coordinate communication with local health authorities, site registration in China, and support CMCRA and China RA registration activities.

Required profile

• University degree in pharmacy or a related field.
• 8+ years of quality experience, including in a foreign pharmaceutical company and cross-functional work.
• Expertise in GMP, quality risk management, and quality management systems and key processes.
• Knowledge of current technology and regulatory trends, and of process control methods such as Ppk and FMEA.
• Good English and computer skills, strong quality mindset and communication skills.