Join us as our Global Quality Audit (GQA) team Director of Quality Compliance, a pivotal role as audit business process owner, responsible for ensuring effective audit methodology! This role is central to integrating regulatory intelligence on GMP into our operations, translating information into GQA procedures, and updating audit protocols to align with current standards. In addition to implementing and monitoring our audit procedures, you will lead and manage highly complex and strategically vital GMP audits.

What you will do:

• Serve as a knowledge resource for the entire team and aid GQA Leadership in interpreting GMP norms. Expected to stay current with industry trends, regulatory perspectives, and anticipations.

• Develop and refine the pharmaceutical quality system and methodology for GMP audit

• Carry out audits at AstraZeneca production locations, and third-party vendors

• Participate in due diligence assessments and conduct other specialized audits that require expert technical knowledge and skills

Minimum Qualifications:

• Minimum of 15 years of experience in QA with demonstrated advanced technical QA understanding of CGMP, audit skills, communication skills, and managerial and leadership capabilities.

• Bachelor's degree in a scientific discipline

• Self-directed and highly motivated team player with solid organizational capabilities

• Cross-cultural awareness and sensitivity, with experience working in cross-cultural settings.

• Ability to travel extensively (up to 60% of time local/regional/global)

• Proven ability to continually refresh CGMP interpretation and application through self-study and external involvement with industry groups.

• Solid knowledge of modern quality systems, risk assessment, corrective and preventive action development and execution, and other evolving principles across the global compliance arena.

• Direct and increasingly responsible audit responsibilities

• Solid awareness of related functional areas such as product development

• Well-advanced written and oral communication skills

Preferred Qualifications:

• International assignment or other intensive cross-cultural responsibilities

• Advanced degree in a scientific or business field

• Experience in other GXP areas (GLP, GCP)

At AstraZeneca, our work in Quality is important and valued. We are always innovating, and trialing the latest models and technologies to improve reliability and excellence in our processes. We draw learnings from others, to develop and understand what it takes to drive our modern mindset forward. Here you'll feel empowered to step up and follow the science and evidence to make decisions that put patients first.

Are you ready to make a difference? Apply today to join our team as the Director of Quality Compliance!

Date Posted

03-Sep-2024

Closing Date

16-Sep-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.