Accountabilities:

All or some of the specific accountabilities applies to the job holder, as fit for the role. As a member of the QA leadership Team we are collectively accountable for the QA team remit and deliverables.

Following applies in detail or as support:

• Actively supports the QA team remit and strategic direction
• Accountable for design, delivery and review of an effective audit program
• Provides proactive, strategic QA advice using tools to functional and therapeutic areas, submission excellence activities, inspection readiness, risk assessment and quality oversight
• Provides effective compliance and risk reporting to senior management across R&D and supports strategic QA governance forums
• Accountable for reporting of quality and quality related risks and compliance gaps to Audit Committee and senior management and across the R&D functions.
• Manages significant compliance incidents and investigations as required
• Worldwide monitoring of GxP regulations and health authority inspection trends
• Responsible for submission-related regulatory inspection support strategy, oversight and response and interacts with relevant regulatory authorities.
• Contributes to Due Diligence activities

Line Management activities:

• Accountable for development of assigned staff and achievement of performance standards, capability and effective organizational leadership
• Optimise the business performance of direct reports to ensure an effective QA organization
• Contributes to functional budget management

Quality Assurance General Accountabilities:

• Ensures own and team’s tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines
• Drives, promote and embeds a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
• Communicates effectively with QA colleagues and cross functional business stakeholders at all levels
• Maintains knowledge of relevant industry information affecting quality and compliance arena
• Leads training for colleagues and business stakeholders as required.
• Ensures, are involved in or may lead the development and/or revision of QA processes,  projects and tools
• Coaches and mentors QA colleagues
• Provides general support related to regulatory authority inspections as and when required
• Provides expert advice on relevant quality and compliance matters across the GxP areas
• Drive and ensure implemention of QA owned strategic initiatives

Qualifications and Experience:

Essential:

• Significant experience in pharmaceuticals or a related industry
• Excellent analytical, written and oral communications skills
• Fluent in written and spoken English
• High ethical standards, trustworthy, operating with absolute discretion
• Strong collaborative, influencing and interpersonal skills – curious to understand business environment
• Skilled at managing & using technology
• Ability to maintain and create professional networks with stakeholders
• Experience in managing regulatory health authority GxP Inspections
• Audit expertise
• Demonstrable leadership skills and experience

Desirables:

• Project management
• Key Account management
• Passion for structure and simplifications
• Driving and implementing strategic initiatives

Date Posted

Closing Date

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.