Regional Hub Director - Global Quality Audit

The Regional Hub Director positions establishes a continuum at the senior level for carrying out more highly skilled audits and acting as a director responsible for 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 cGMPs. The incumbents in these roles possess advanced audit skills and specialized technical expertise, e.g. aseptic manufacturing, inhalation drug products, etc. The Regional Hub Director role also requires proven managerial and leadership experience within a global role.

The job holder is an experienced Senior QA Professional in possession of considerable audit experience and with proven managerial/leadership skills in a technical role. The job holder is responsible for leading the audit staff within one of the 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.

The individual is also required to be knowledgeable with modern quality systems and the evolving application of such systems across both the development and manufacturing arenas.

Job Responsibilities

• Conduct independent appraisals of quality and compliance systems within technically advanced manufacturing settings
• Performs complex and demanding domestic and international audits of suppliers of chemicals, packaging components, finished drug products, or contracted services. Audits are conducted in accordance with cGMPs, ISO Standards, IPEC, ICH Q7A and company procedures.
• Plans, coordinates, and conducts scheduled or unscheduled cGMP audits of complex internal AstraZeneca Operational departments to ensure compliance to cGMPs and AstraZeneca standards
• Develops training programs and trains auditors on more complex audits; supports planning the global audit program and identifying continuous improvement opportunities
• Develop and maintain performance measurements to improve and assess the performance for the site Audit Program. Responsible to establish peer-reviews of audit reports.
• Coordinate and deliver the yearly audit schedule for the region. Will be responsible for the day-to-day oversight of the regional external audit program and coordinating 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, where necessary, to ensure issues are understood and proposed actions are acceptable
• Interpret and apply cGMP regulations and expectations
• Well advanced written and oral skills with experience working in cross-cultural settings globally
• Initiate and maintain close contacts with regulatory agencies and/or industry/professional organizations to keep 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 in a proactive manner
• While maintaining independence, work closely with other QA colleagues to assure common understanding of developing interpretations of cGMP
• Demonstrated and proven leadership skills in leading technical groups
  
  
  

Typical Accountabilities

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance.
• Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Ethics and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns, and (d) immediately addressing and reporting, as appropriate, instances of non-compliance
• Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities and Fiscal and Financial awareness
• Leaders with accountability for GxP areas are expected to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial material, facilities, and equipment) to maintain the Quality system and continually improve its effectiveness
• Ensure that roles, responsibilities, and reporting lines are clearly defined throughout the organisation, to assure a functionally independent quality unit.
• Ensure sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency
• Ensure continuing suitability and effectiveness of the quality management system, product quality and GMP/GDP compliance through participation in management reviews and through advocating continual improvement
  
  
  

Essential

Education, Qualifications, Skills, and Experience

• Significant experience (typically more than 12 years) 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
  
  
  

Desirable

• 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)