Associate Director, Quality Assurance APAC

As the independent second line quality assurance function for R&D, our mission in Quality Assurance is to achieve enduring excellence in auditing, quality management, quality risk assessment and enhance the R&D quality mindset for the benefit of our patients.

The Associate Director Quality Assurance is responsible for:

• Planning, leading, conducting, and reporting R&D GxP risk-based audits across GCP, GVP, GRP, Lab GCP, and GLP, with a focus on assessing emerging technologies, AI solutions, computerized systems, digital processes, and technology-enabled quality activities.

• Delivery of proactive GxP inspection support and management

• Management of significant CAPAs related to audit and/or inspection findings in collaboration with functions owning the issues.

• Managing business relationships with defined stakeholder groups for the quality management activities (quality risk, issues, process etc.).

Responsibilities:

Audit

• Plans, leads, conducts and reports audits in assigned GxP areas, and types e.g. investigator site audit, system or process audits and vendor audits, with particular focus where applicable on computerized systems, digital platforms, data integrity, technology-enabled processes and AI solutions.

• Participate in and may lead directed (For Cause) audits.

• Works with contract personnel or consultants to prepare, conduct and report outsourced audits

Service provider quality oversight

• Provide quality oversight of service providers, including supplier qualification activities, gap assessments, and due diligence support, particularly where services involve digital systems, data platforms, AI-enabled tools, or regulated technology solutions.

CAPA

• Assesses need for, and assists in development of CAPA plans, approves and monitors plans to completion

Inspection

• Provides QA oversight and/or management of regulatory GxP inspections

• Collaborates with Quality Assurance lead, to manage and prepare for regulatory inspections as assigned including providing training to the organisation as needed.

General Accountabilities

• Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines

• Promotes a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits

• Communicates effectively with QA colleagues and business stakeholders

• Maintain knowledge of relevant regulatory expectations, industry trends, and evolving best practices related to GxP, data integrity and governance, computerized systems, digital health technologies, AI governance and quality risk management.

• Leads training for colleagues and business stakeholders as required.

• Involved in and may lead the development and/or revision of QA processes, projects and tools

• Mentors QA colleagues

• Act as a trusted quality partner to stakeholder by providing proactive and practical advice on GxP compliance, quality systems, digital risk, computerized systems quality, and the use of emerging technologies in regulated environments.

• Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations

• Travel expected

Requirements:

Essential

• Degree-level education or equivalent experience in clinical development, quality management, data science, computer science, information technology, AI technology or a related discipline

• Experience in one or more of the following areas: computerized systems, data integrity, digital technologies, AI-enabled solutions, IT quality, CSV/CSA, or technology risk in regulated environments

• Excellent analytical, written and oral communications skills

• Fluent in written and spoken English

• High ethical standards, trustworthy, operating with absolute discretion

• Strong collaborative, influencing and interpersonal

• skills - curious to understand business environment

• Skilled at managing & using technology

• Ability to build effective professional networks with stakeholders across functions and geographies

Desirable

• Experience in auditing or overseeing AI solutions, digital platforms, computerized systems, or other technology-enabled processes in regulated environments

• Experience in computerized system validation (CSV), data governance, or IT quality

• Experience in pharmaceuticals or a related industry

• Project management experience

• Experience in managing regulatory health authority GxP Inspections

• Key Account management

• Audit expertise

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.