【AstraZeneca】【R&D】Associate Director Labs/Audit Quality Assurance, R&D Quality Assurance

■ Short role 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 Associate Director Quality Assurance is responsible for:

• Planning, leading, conducting and reporting audit activities for R&D GxP risk-based audit programs

• 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.

Providing Quality strategic advice in line with R&D strategy and priorities

■Typical Accountabilities

The Quality Assurance GxP accountabilities are split between the QA teams, QA APAC team is working together with audit QA, Labs QA and global Strategic advice team in below:

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.

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

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

• Supports Due Diligence activities as assigned

• Leads Supplier qualification activities (Operational Due diligence ODD) as assigned

• Identify and assess gaps during supplier qualification assessments

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.

Quality Stratrgic Advice

• Providing Quality strategic advice in line with R&D strategy and priorities, including quality management reciew, quality related workshop, training and consultations, etc.

CAPA

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

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

• Domostrate QA leaship in audit, inspection and strategic advice

• 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

• Mentors QA colleagues

• Provides general support  related to regulatory authority inspections as and when required

• 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

• Travel expected

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.