Director, Development Quality Assurance: Vendor Oversight

This is what you will do: 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 vendor quality oversight for internal and external business partners. You will be responsible for: Business Partnering Provides adaptable and proactive quality and compliance advice to stakeholder groups, effectively influencing assigned area by being relevant GxP expert. Provides 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. 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 efficiency 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. Lead a team of staff who will be responsible for the operational aspects of Vendor Quality Oversight, Quality Governance, Documentation, and Training. 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 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 build 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; proficient 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 Date Posted 24-Jun-2024 Closing Date 28-Jul-2024 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.