Job Description

Regional Hub Director - Quality Audit xe2x80x93 GCL FAPAC RegionsIntroduction to roleThe Regional Hub Director position establishes a continuum at the senior level for carrying out highly skilled audits and leading an audit group at a hub location. These positions are responsible for conducting audits of AstraZeneca manufacturing sites, contractors, due diligence, and other audits where specialized expert technical skills and experience are needed. Audits are conducted in accordance with worldwide regulations/guidelines and company quality standards to assure compliance with GMPs. The incumbents in these roles possess advanced audit skills and specialized technical expertise, such as aseptic manufacturing and inhalation drug products. The Regional Hub Director role also requires proven managerial and leadership experience within a global role.You are an experienced Senior QA Professional with considerable audit experience and proven managerial/leadership skills in a technical role. The job holder is responsible for leading the audit team within one of the APAC hubs and serves as an expert resource for the interpretation of any audit observations and the corresponding corrective and preventive actions. The individual is required to be fully attuned to developments in industry practices and regulator interpretations and expectations. Additionally, the individual must be knowledgeable about modern quality systems and their evolving application across both development and manufacturing arenas.Key Accountabilities

• Conduct independent appraisals of quality and compliance systems within technically advanced manufacturing settings

• Perform complex and demanding domestic and international audits of suppliers of chemicals, packaging components, finished drug products, or contracted services in accordance with cGMPs, ISO Standards, IPEC, ICH Q7A, and company procedures

• Plan, coordinate, and conduct scheduled or unscheduled cGMP audits of complex internal AstraZeneca Operational departments to ensure compliance with cGMPs and AstraZeneca standards

• Develop training programs and train auditors on more complex audits; support planning the global audit program and identify continuous improvement opportunities

• Develop and maintain performance measurements to improve and assess the performance of the site Audit Program; establish peer-reviews of audit reports

• Coordinate and deliver the yearly audit schedule for the region; oversee the regional external audit program and coordinate audit schedules for all external audits

• Provide clear and scientifically/technically justified interpretations and support for any audit findings and proposed corrective and preventive actions

• Liaise directly with local AZ and/or regional and global senior management to ensure issues are understood and proposed actions are acceptable

• Interpret and apply cGMP regulations and expectations

• Initiate and maintain close contacts with regulatory agencies and/or industry/professional organizations to stay aware of trends and initiatives in quality assurance, GMP compliance, and inspections

• Develop and interpret audit findings across the scope of the Global Quality Audit (GQA) to communicate trends and provide recommendations to address such developing trends proactively

• Work closely with other QA colleagues to assure a common understanding of developing interpretations of cGMP while maintaining independence

• Demonstrate proven leadership skills in leading technical groups

Essential Skills/Experience

• Significant experience in both QA and pharmaceutical operations units, with demonstrated advanced technical QA understanding of cGMP, audit skills, communication skills, and proven 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

• 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 English language skills in both written and oral with experience working in cross-cultural settings globally

Desirable Skills/Experience

• International assignment or other intensive cross-cultural responsibilities

• Advanced degree in a scientific discipline

• Advanced degree in a business discipline

• Experience in other GXP areas (GLP, GCP)

At AstraZeneca, our work in Quality is important and valued. We have an unrivalled forward-looking mindset that allows us to work at the forefront of innovation, adding real value throughout the lifecycle of our productsxe2x80x94from discovery to development to commercialization.As the voice of the patient, every batch we certify is a personal stamp of approval. We are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes. Here you'll feel empowered to step up, follow the science, make decisions that put patients first, and work collaboratively with a team that shares your passion for excellence.Ready to take on this exciting challenge? Apply now!Date Posted 28-Nov-2024Closing Date 12-Dec-2024AstraZeneca 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.

AstraZeneca