Director, Quality Assurance APAC

At AstraZeneca we’re dedicated to being a Great Place to Work. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.  We’re focused on the potential of science to address the unmet needs of patients around the world.  We commit to those areas where we think we can really change the course of medicine and bring new ideas to life.

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.

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 (GCP, GVP, clinical GCP, GLP) and quality management activities for these stakeholders. You will also be responsible for conducting complex audit as assigned, and delivery of proactive end‐to‐end GXP inspection support and management.

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 (GCP, GVP, clinical GCP, GLP)

• 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

Requirements:

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

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.