Software Quality Assurance Director jobs in Bear, DE

Global Quality Associate Director – US Marketing Company Quality Cluster Lead

Introduction to Role:

Are you ready to oversee the design, implementation, and delivery of a common Quality system and strategy for GMP and GDP activities across the US Commercial marketing company for all of the AZ product portfolio in region? This role participates in the development of Global AZ Marketing Company Quality Strategy and executes strategy for Marketing Company Quality and Marketing Company GMP/GDP aligned with AZ’s 2030 bold ambition strategy for market expansion, product launches, and accessibility.

Accountabilities:

As the Global Quality Associate Director, you will develop, support, and drive excellence in Marketing Company GMP&GDP Quality activities to maintain the local License to Operate. You will be the primary point of GMP&GDP contact for the region and maintain an effective governance structure to ensure oversight of quality activities. You will provide leadership for GMP & GDP strategy and activities across markets and commercial SET area in Market as the Quality partner to Commercial SET leaders, Regional Commercial Heads, and Global Patient Safety.

Essential Skills/Experience:

• Bachelor's degree and minimum of seven years of relevant experience.

• Demonstrated expert level knowledge of GMP/GDP quality management systems, within pharma or biopharma industry.

• Experience in GMP/GDP country or operational roles.

• Knowledge of country specific regulatory requirements related to manufacture and distribution of pharma or biopharma product, including resolution of Issue Management, FARs, BPDRs, recalls, influence and decisions on local regulatory agency interactions, audits and inspection readiness.

• Ability to deliver near and longer term Marketing Company GMP/GDP strategy across market in AZ Commercial network and partners.

• Excellent communication and organization skills with ability to make decisions and influence outcomes related to patient supply and AZ reputation.

• Strong business acumen with Integrity and high ethical standards.

• A broad understanding of the technical requirements within Quality and an ability to balance this with industry standards to achieve business goals.

Desirable Skills/Experience:

• Master's degree, preferred with five plus years of experience.

• Line management experience

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?

In Quality, our work is important and valued. An unrivalled forward-looking mindset, there's no better place to work at the forefront and learn how to add real value to a business throughout the lifecycle of our products. discovery, development and commercialization. As the voice of the patient, every batch we certify is a personal stamp of approval. Not something we take lightly, we are always innovating, trialing the latest models and technologies to improve reliability and excellence in our processes.

Are you ready to accelerate our Lean journey? Take advantage of the huge opportunities to drive efficiencies in our processes and produce better-quality outputs. Now is the time to join and make a bigger impact, as we commit and accelerate our growth in Lean.

Apply now to be part of our ambitious team!

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.