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 Audit) 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 audit 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 Audit/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!
Date Posted
19-Sep-2024Closing Date
29-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.