Director, 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 Blue Sky 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.

Are you looking for an opportunity to expand your skills and experience?

Do you want to join a dynamic team and help create new strategies in the R&D QA Audit Program?

We have a fantastic opportunity as the Director, R&D QA within R&D QA Audit. Would you like to develop and lead a new audit strategy for Process and Systems audit, influencing a wide cross section of collaborators from all areas of the business? Do you have experience in establishing new ways of working? If so, this is the right opportunity for you!

WHO IS R&D QUALITY ASSURANCE
We are 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 improve the R&D quality attitude for the benefit of our patients.

WHAT DOES

THE ROLE INVOLVE
As the Director, R&D QA you will be the Strategy Lead for Process & Systems audit and an extended member of the Audit Leadership Team. The role will report to the Executive Director Audit Quality Assurance.

Tell me more
Audit-LabsQA are responsible for the strategic development and delivery of the GxP regulated risk-based audit programme, the Clinical Supplier Qualification Assessment process, and coordinates business relationship management with functions and senior leaders.

Delivery of the R&D GxP Audit Programs includes audit of systems / processes, service providers, country level GCP/GVP functions, clinical studies, labs and device. Current advancements in regulations are driving the evolution of the Audit Programs.

What will I be accountable for?

Support quality risk management for designated area to define audit strategy recommendations

Maintains strong business relationship with relevant business partners

Provide effective compliance reporting to senior management and contributes to strategic QA governance forums

Contributes to functional budget management

Plans, leads, conducts and reports sophisticated audits in all or some of the GxP areas e.g. system or process audits

Conducts due diligence activities as assigned

Leads Directed (For Cause) audits.

Drive, promote and embed a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits

Communicate effectively with QA colleagues and cross functional collaborators at all levels

Maintain knowledge of relevant industry information affecting quality and compliance arena

Travel expected

REQUIRED SKILLS AND CAPABILITIES

Significant experience in the pharmaceutical industry (10 years), audit expertise and deep knowledge in GxP regulations.

Demonstrated knowledge of GxP Process management, ownership and interdependencies.

Experience at developing and managing stakeholder relationships.

Experience at managing regulatory health authority GxP Inspections within the Pharmaceutical industry

High ethical standards, trustworthy, operating with absolute discretion.

Strong collaborative, influencing and interpersonal skills.

Ability to maintain and build professional networks with partners.

Ability to lead a team and experience working globally.

A nnualbase salary for this position ranges from $143,000 to $188,000 AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations.

The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term…