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 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 were 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.

Annualbase salary for this position ranges from $143000 to $188000 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 ina majority ofsituations. The base pay offered will vary depending on multiple individualized factors including the candidates skills and experience job-related knowledge and other specific business and organizational 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 Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits &Retirement Savings Program 4 weeks paid vacation and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 10 years
• Top 100 Employers Award
• Canadas Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel

Are you interested in working at AZ apply today!

AstraZenecais 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.

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.