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SalaryAssociate Director Labs/Audit Quality Assurance
Join us as an Associate Director LabsQA where you will conduct audits of laboratories internally and externally at our suppliers. Reporting to the Senior Director LabsQA, you will support inspections and manage CAPAs related to audit and inspection in collaboration with partners. The LabsQA Team are responsible for the strategic development and delivery of a risk-based audit programme covering the following Quality Standards / areas: GLP, Lab GCP, Human Biological Samples, and our internal research quality standard “GLS” risk-based audit program. We also conduct Supplier Qualification Assessments to verify that suppliers meet AZ quality expectations.
Accountabilities:
In this role, you will be responsible for planning, leading, conducting, and reporting audit activities. You will provide responsive and proactive quality and compliance advice to collaborators, effectively influence assigned area by being relevant GxP/quality system expert, and support regulatory authority inspections when required. You will also lead training for colleagues and business collaborators as required, promote a quality mindset culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and business benefits, support or lead the development and/or revision of QA processes, projects and tools, communicate effectively with QA colleagues and business collaborators, maintain knowledge of relevant industry information affecting GxP quality and compliance, support quality and compliance risk management for functional area, and travel as expected.
Essential Skills/Experience:
Audit experience in pharmaceuticals or a related industry, i.e., laboratories involved in GLP, Lab GCP, HBS and CAP/CLIA
Sound knowledge of the regulatory requirements associated with the pharmaceutical industry, specifically laboratories.
Integrity, ethical judgement, and a high standard of professional conduct while maintaining independence and objectivity
Good analytical and critical thinking ability to assess and clearly communicate risks associated with complex systems and processes
Effective communication skills including authoring reports, presenting findings to collaborators with clarity and tact.
Good collaborative and people skills fostering a cooperative team environment and building relationships with partners
An appetite for continuous learning and adaptability to the changing technological and regulatory landscape
Desirable Skills/Experience:
Project management experience
Experience in managing regulatory health authority GxP Inspections
Key Account management
Audit expertise
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca?
Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing ground breaking science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025. A place built on courage, curiosity and collaboration. we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team.
Are you ready to make a difference? Apply now and join us in our mission to eliminate cancer as a cause of death!
