Manager Audit Quality Assurance (GCP)

at  AstraZeneca

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:

• Planning, leading, conducts and reports audit activities for R&D GxP risk-based audit programs
• Support of GxP inspection activities
• Management of CAPAs related to audit and/or inspection findings in collaboration with QA colleagues and functions owning the issues.
• Support of QA activities such as CAPA tracking & follow-up
• 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
• Maintains knowledge of relevant industry information affecting quality and compliance arena
• May provide responsive and proactive quality and compliance advice to defined customers.
• Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
• Travel expected

The Quality Assurance GxP accountabilities are split between the QA teams as below:·

• Audit team - GCP, GVP, GRP, including strategy where applicable
• LabsQA team - GLP, HBS, GLS, ISO 17025, CLIA including strategy

Audit

• Plans, leads, conducts and reports audits in assigned GCP areas, such as investigator site and/or project audits
• Supports lead auditors in the planning, conduct and reporting of more complex audits such as Process / System, External supplier
• Works with contract personnel or consultants to prepare, conduct and report outsourced audits
• Supports Supplier qualification activities (Operational Due diligence ODD) as assigned
• Identify and summerize gaps during ODD

• Planning, leading, conducts and reports audit activities for R&D GxP risk-based audit programs
• Support of GxP inspection activities
• Management of CAPAs related to audit and/or inspection findings in collaboration with QA colleagues and functions owning the issues.
• Support of QA activities such as CAPA tracking & follow-up
• 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
• Maintains knowledge of relevant industry information affecting quality and compliance arena
• May provide responsive and proactive quality and compliance advice to defined customers.
• Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
• Travel expecte