Director, APAC Quality Assurance

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 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 assigned
• Works with contract personnel or consultants to prepare, conduct and report outsourced audits as required
• Monitors risk and compliance intelligence for assigned GXP area
• Communicate 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 groups
• Provides responsive and proactive quality and compliance advice to stakeholder groups, effectively influencing assigned area by being relevant GxP expert
• Provides effective compliance reporting to senior management and supports strategic QA governance forums
• Supports quality and compliance risk management for stakeholder groups
• Supports Due Diligence activities as assigned.

Inspection

• Provides QA oversight and leadership for regulatory GxP inspections
• Responsible 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 completion
• Oversees 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 expert
• Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
• Maintains strong business relationship with relevant business stakeholders
• Provide effective compliance reporting to senior management and contributes to strategic QA governance forums
• Contributes to functional budget management
• Travel expected

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 at all levels
• Maintains knowledge of relevant industry information affecting quality and compliance arena
• 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
• Coaches and mentors QA colleagues
• Provides general support related to regulatory authority inspections as and when required

Education, Qualifications, Skills and Experience

Essential

• Degree level education or equivalent experience
• Significant experience in pharmaceuticals or a related industry
• 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 maintain and create professional networks with stakeholders
• Experience in managing regulatory health authority GxP Inspections
• Audit expertise

Desirable

• Project management experience
• Experience of six sigma/lean/process improvement tool
• Key Account management      

【AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised. 阿斯利康是一家提供平等机会的企业，我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份（如果适用）及任何其他受法律保护的特征而产生歧视。】

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 authorisation and employment eligibility verification requirements.