＜Job Description＞

As the independent second line 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 job holder is responsible for one or multiple of the following areas:

The job holder is responsible for managing business relationships with defined stakeholder groups and senior leaders in R&D and for the strategic development and delivery of a GXP risk based robust quality assurance program and quality management activities for these stakeholders. Additionally, the job holder is responsible for conducting complex audit as assigned, and delivery of proactive end‐to‐end GXP inspection support and management.

＜Typical Accountabilities＞

Audit

Plans, leads, conducts and reports complex audits in all or some of the GxP areas, and types e.g. investigator site audit, system or process audits and supplier audits.May maintain and update the resource management system for a QA region in a timely manner (i.e. APAC)Conducts due diligence activities as assignedWorks with contract personnel or consultants to prepare, conduct and report outsourced audits as requiredMonitors risk and compliance intelligence for assigned GXP areaCommunicate and assess the standard of audits expected and delivered in their area of responsibility (as applicable)Leads directed (For Cause) audits.

Business Partnering-APAC local strategic advice

Leads strategic direction on quality and compliance through engagement with defined stakeholder groupsProvides responsive and proactive quality and compliance advice to stakeholder groups, effectively influencing assigned area by being relevant GxP expertProvides effective compliance reporting to senior management and supports strategic QA governance forumsSupports quality and compliance risk management for stakeholder groupsSupports Due Diligence activities as assigned.

Inspection

Provides QA oversight and leadership for regulatory GxP inspectionsResponsible for delivery of end-to-end submission-related regulatory inspection strategy , leads or supports Quality Assurance team members, to manage and prepare for regulatory inspections, including providing pre- inspection training to the organisation as needed.

CAPA

Assesses need for, and assists in development of CAPA plans, approves and monitors plans to completionOversees significant CAPAs for clinical activities in R&D in APAC region

Job specific Accountabilities

Provides responsive and proactive quality and compliance advice to defined customers, effectively influence assigned area by being relevant GxP/quality system expertSupport quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendationsMaintains strong business relationship with relevant business stakeholdersProvide effective compliance reporting to senior management and contributes to strategic QA governance forumsContributes to functional budget managementTravel expected

General Accountabilities

Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelinesPromotes a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefitsCommunicates effectively with QA colleagues and business stakeholders at all levelsMaintains knowledge of relevant industry information affecting quality and compliance arenaLeads training for colleagues and business stakeholders as required.Involved in and may lead the development and/or revision of QA processes, projects and toolsCoaches and mentors QA colleaguesProvides general support related to regulatory authority inspections as and when required

＜Requirements＞

Essential

10+ years' experience of GCP in Pharmaceutical industryDegree level education or equivalent experienceSignificant experience in pharmaceuticals or a related industryExcellent analytical, written and oral communications skillsFluent in written and spoken EnglishHigh ethical standards, trustworthy, operating with absolute discretionStrong collaborative, influencing and interpersonal skills – curious to understand business environmentSkilled at managing & using technologyAbility to maintain and create professional networks with stakeholdersExperience in managing regulatory health authority GxP InspectionsAudit expertise

Desirable

Project management experienceExperience of six sigma/lean/process improvement toolKey Account management

Date Posted

14-8月-2025

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.