Clinical Quality Associate Director

2 months ago

Blenheim Road, Australia AstraZeneca Full time

Are you passionate about making a positive and impactful difference to the lives of others and want to add value with your Quality background? Join AstraZeneca as a Clinical Quality Associate Director working in our Clinical Research team.

**About AstraZeneca**

Equally driven by purpose and performance, we are recognised and respected within the industry and by our peers. We are renowned for doing the right thing, and those we work with - from clinicians to doctors - admire our work and ambitions. Join our team and feel proud to work for a company with an enviable reputation, which stands firm and is well positioned to be a market leader in Australia and New Zealand.

We will help you expand your skills and knowledge and unlock your best. Working at pace, you’ll be challenged and supported to grow - learning from inspiring leadership and exceptional teams who believe in the power of science to make a difference. Every day you will broaden your horizons and skills, finding opportunities to take the initiative and build a meaningful career. Our outstanding learning resources and new diverse career-enhancing opportunities will quickly deepen your personal and professional growth.

**What you’ll do**

In this role, you will provide compliance and process advice to the local Site Management and Monitoring team and identify opportunities for quality and process improvements on local, regional and global level. As our quality compass, you will work with a passionate and collaborative team to ensure we maintain high quality and safety in delivering new medicines through our clinical trial program.

As the Clinical Quality Associate Director (CQAD), you will be responsible for the maintenance, further development, and the communication of high-quality standards in the delivery of clinical studies. This includes a key role in ensuring that the training needs in the local SMM team are fulfilled in cooperation with the local SMM leadership team.

Based out of our Sydney office and reporting to the SMM Biopharmaceuticals Country Head, we have an exciting 9-month contract role, in either a full or part time capacity.

**Essential for the role**:

- Bachelor's degree or equivalent in a related discipline, preferably in life science
- Experience in Development Operations/Quality Assurance within the pharmaceutical industry
- Good knowledge of international guidelines ICH-GCP as well as relevant local regulations
- Good understanding of the drug development process and related GXP activities
- Good understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g., ICH-GCP, study management, site management, monitoring
- Excellent organisational skills along with an exceptional ability to prioritize and handle multiple tasks
- Excellent communication and interpersonal skills
- Good presentation skills and ability to learn and to adapt to work with IT systems
- Ability to manage change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business
- Ability to travel nationally and internationally as required
- Demonstrate a learning and flexible mindset, strong active listening and coaching skills. Along with a risk based approach to ICH-GCP and focus on what really matters to our patients and trials.

**Desirable for the role**:

- Ability to interact widely and effectively within the company at all levels.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time
- Good analytical, problem solving, negotiation and conflict resolution skills

**Why AstraZeneca**

At AstraZeneca, we share and are motivated by the same purpose: pushing the boundaries of science in order to deliver life-changing medicines to patients around the world. In short, our work has true meaning. As a business, we are committed to people. Our patient first approach informs all our decision making and we invest in team and individual development. Ours is an energetic, fast paced way of working that is solutions focused and collaborative.

AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA) and as a Bronze Tier Employer within the Australian Workplace Equality Index (AWEI). Visit our ANZ Careers Page to learn more about our commitment to fostering a flexible, diverse, and inclusive environment.

**So, what’s next?**
- We want to unlock your potential and inspire you to be your best, challenging you to expand your horizons, extend your knowledge and grow to your fullest. Join us to unlock your best
- If you’re curious to know more, please reach out to Danielle Jones.

**Where can I find out more?

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