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Director, Development Quality Assurance: Regulatory Affairs
hace 3 meses
As part of the Development Quality Assurance Team, you will drive Quality Culture with stakeholders by partnering on quality topics, embedding a quality mindset, and executing on continuous improvement opportunities. You will be responsible for managing business relationships with defined stakeholder groups and leaders in Development, Regulatory and Safety functions and for the strategic development and delivery of risk-based quality management and global regulatory affairs quality oversight for internal and external business partners. You will be responsible for: Business Partnering Provide responsive and proactive quality and compliance advice to stakeholder groups, effectively influencing assigned area by being relevant GxP expert. Provide effective compliance reporting to senior management and supports strategic QA governance forums. Drive the quality management system governance model for the Alexion Rare Disease Unit (ARDU) in line with AZ Standards. Regulatory Affairs Quality Oversight Partner with Global Regulatory Affairs (GRA) and functional personnel to implement and support quality and compliance standards in accordance with global regulatory requirements and Alexion/AZ values. This includes working effectively with GRA stakeholders to understand functional interdependencies and to develop mutually agreed optimized processes. Assure effectiveness of business processes and compliance with adequate regulations. Support the CAPA investigation, review, and approval process for GRA-owned Quality Events (including audit and inspection findings and deviations). Collaborate with GRA on Standard Operating Procedure (SOP) development serving as quality approver. Quality Management Oversight and monitoring of the ARDU Quality Management System (QMS) to enable a quality culture and promote continued compliance. Establishing, monitoring, and reporting of Key Quality Performance Indicators and metrics to meet business needs and regulatory requirements. Providing proactive interpretation of quality and compliance metrics data for inclusion in periodic reports and dashboards. Assure effectiveness of business processes and compliance with adequate regulations. Drives continuous process improvement with simplification, standardization, and improved user experience in collaboration with functions/system and business process owners. Drive strategy to ensure learning curricula are fit for purpose for job roles. General Accountabilities Ensuring own tasks are performed to current practices and in accordance with company policies, standards, SOPs, and guidelines. Assists in inspection readiness and preparation, and/or directly supports regulatory agency inspection. Assists in coordination of responses to any findings, as applicable. Contributes to Due Diligence activities. Accountable for development, coaching, and mentoring of assigned staff and achievement of performance standards, capability, and effective line management. Maintaining knowledge of relevant industry information affecting quality and compliance arena. Involved in and may lead the development and/or revision of QA processes, projects, and tools. You will need to have: Bachelor's or Higher Degree in life sciences or similar scientific subject Minimum of 12 years of experience in pharmaceutical industry, with significant experience in Regulatory Affairs, Good Clinical Practice/Good Pharmacovigilance Practice or Good Clinical Practice/Good Pharmacovigilance quality assurance and compliance. Strong collaborative, influencing and interpersonal skills – curious to understand business environment Ability to maintain and create professional networks with stakeholders Demonstrated ability to prioritize workloads through effective decision making High attention to detail and accuracy Proficiency in developing presentations to facilitate meaningful discussions, with clearly communicated analysis, findings, and impact. High ethical standards, trustworthy, operating with absolute discretion Effective leadership skills Excellent communication skills; fluent oral and written English We would prefer for you to have: Good analytical, problem-solving and negotiation skills Experience in working in a global role Cultural Awareness and Positive Attitude in managing change Experience with the Veeva Quality modules Project Management experience Quality Management experiences Prior people management experience Location: Barcelona When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. 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. #J-18808-Ljbffr
