Manager Audit Quality Assurance
At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
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
The Quality Assurance GxP accountabilities are split between the QA teams as below:·
Audit team - GCP, GVP, GRP, LabGCP including strategy where applicable
Audit
Plans, leads, conducts and reports audits in assigned GxP 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 summerise gaps during ODD
CAPA
Assesses need for, and assists in development of CAPA plans, approves and monitors plans to completion for assigned audits
Assists with the continuing follow-up of agreed audit CAPA actions from across QA to assist in the monitoring of QA Key Performance Indicators
Inspection
May support Quality Assurance colleagues to prepare for regulatory inspections and assist with planning and logistical arrangements
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
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
Education, Qualifications, Skills, and Experience
Degree level education or equivalent experience
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
Collaborative, influencing and interpersonal skills – curious to understand business environment
Skilled at managing & using technology
Ability to develop professional networks with stakeholders
Desirable:
Audit Experience
Supplier qualification
Experience of regulatory health authority GxP Inspections
Great People want to Work with us! Find out why:
Are you interested in working at AZ, apply today!
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.
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.
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