Global Quality Assurance Snr Director, Proactive Compliance & Innovation
AstraZeneca

Job Info

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Introduction to role

Location: US, Gaithersburg, MD

*Travel: Up to 50% (includes domestic and international) *

Are you ready to champion a mindset of excellence? We are seeking a forward-thinking GQA (Global Quality Assurance) Senior Director, Proactive Compliance & Innovation. This role is pivotal in integrating regulatory and compliance knowledge throughout AZ Operations, managing GQA's internal processes, and keeping abreast of evolving cGMP regulations and enforcement trends. You will be expected to effectively implement GQA auditing procedures, leverage data analytics, and champion proactive quality compliance measures at AZ. This is a unique opportunity to join an environment of excellence, where we're backed by a belief that good can always be better.

Accountabilities

As the GQA Senior Director, you will lead GQA Proactive Quality Initiatives and Improvement Programs aimed at ensuring forward thinking compliance and continuous improvement. You will be accountable for the performance and effectiveness of the Proactive Compliance functions of the GQA organization, including managing self-inspections, audit quality systems, and data analysis. You will maintain strong relationships with international regulatory and professional bodies, building an external network that is effective in maintaining a positive regulatory compliance reputation. You will also oversee compliance against the GQA policies and standards, ensuring relevant Standard Operating Procedures are developed, communicated, and implemented. You will execute audits at AstraZeneca's global production locations, conforming to global regulatory guidelines and corporate quality norms to verify adherence to cGMPs, particularly where this requires the highest level of GMP technical skills and experience. Furthermore, you will be responsible for expenditure versus budget within GQA Proactive Compliance activities.

Essential Skills/Experience:

• Bachelor's Degree or equivalent professional qualification in a science/technical field such as Pharmacy, Biology, Chemistry, and ten plus years of relevant industry experience.
• Extensive experience in multiple areas of quality assurance delivery within a pharmaceutical manufacturing environment, with focus on audits and investigations.
• Extensive regulatory experience, including GMP inspection and external collaboration activities.
• Experience in leading and managing a Quality Assurance/Quality Control function and of delivering improvements.
• Demonstrates the highest level of GMP technical skills and experience.
• Ability to influence senior stakeholders, both internally and externally.

Preferred:

• Post-graduate qualification
• Qualified Person
• Experience working for a regulatory organization such as FDA or EMA.

At AstraZeneca, we take Quality seriously. Our work is important and valued. We are proactive, science-based, and solutions-oriented. We are a team of ambitious people who want to go far. We follow evidence to reach outcomes that benefit patients and AstraZeneca. We adapt to get new medicines out quicker. Our focus is on scaling and introducing new technologies, using models to predict and proactively manage risk. We share knowledge and ways of working. Here each voice matters and it instils a real sense of camaraderie.

Are you ready to make a difference? Apply now to join our team in Operations as the GQA Senior Director, Proactive Compliance & Innovation!

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.

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