Senior Manager, Digital Quality Management Systems, Business Analyst

📋 Description

• • As a Senior Manager, Digital Quality Management Systems Business Analyst at BeiGene, Ltd., you will play a pivotal role in shaping and executing the strategy for our digital Quality Systems. This remote position within the US is crucial for ensuring our technology solutions not only meet but exceed regulatory requirements and business objectives in the fight against cancer.
• • You will serve as the primary business System Owner for critical GxP digital systems, such as eQMS and QualityDocs, taking ownership of their entire lifecycle from implementation through ongoing enhancements and maintenance.
• • Your responsibilities will include meticulously gathering and translating complex business needs into clear, actionable functional and technical requirements, acting as the bridge between Quality, IT, and various business stakeholders.
• • A significant aspect of this role involves driving continuous improvement and digital transformation initiatives across the Quality organization, leveraging technology to optimize processes and enhance compliance.
• • You will foster strong, collaborative relationships with cross-functional teams, including Quality Assurance (QA), Information Technology (IT), Regulatory Affairs, Clinical Operations, and external vendors, ensuring seamless alignment of systems with the overarching business strategy.
• • Developing and maintaining robust relationships with business process owners will be key to ensuring that our digital systems consistently meet evolving business needs and regulatory landscapes.
• • You will be instrumental in planning and leading User Acceptance Testing (UAT), comprehensive training programs, and effective change management activities for all new system features and implementations, ensuring smooth adoption and user proficiency.
• • Project management is a core component of this role, requiring you to effectively manage project scope, timelines, resources, budgets, and risks, proactively identifying and escalating issues as needed to ensure successful project delivery.
• • A fundamental duty is to ensure ongoing system compliance with all applicable GxP regulations, including FDA, EMA, and ISO standards, maintaining the integrity and reliability of our quality data.
• • You will be responsible for preparing and delivering high-quality project updates, clear stakeholder communications, and thorough system documentation, ensuring transparency and informed decision-making across the organization.
• • You will oversee the governance, configuration, and administration of digital quality tools, such as Veeva QMS, ensuring strict adherence to organizational policies and compliance standards, while simultaneously optimizing system functionality to improve user experience and operational efficiency.
• • Developing and implementing robust master data management practices will be essential to guarantee data accuracy, consistency, and integrity across all digital quality tools, thereby facilitating informed decision-making and upholding stringent regulatory requirements.
• • This role demands a proactive approach to identifying opportunities for process optimization and digital maturity enhancement within the Quality function.
• • You will contribute to a culture of scientific rigor and business excellence, embodying BeiGene's core values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit.
• • By fostering teamwork, providing actionable feedback, demonstrating self-awareness, acting inclusively, taking initiative, embracing an entrepreneurial mindset, committing to continuous learning, embracing change, and maintaining a results-oriented approach, you will directly contribute to BeiGene's mission.
• • Your analytical thinking and data analysis skills will be vital in assessing system performance and identifying areas for improvement.
• • You will also contribute to financial excellence by managing project budgets effectively and ensuring cost-efficient system solutions.
• • Clear and concise communication will be paramount in all interactions, from technical documentation to stakeholder presentations.
• • This position offers a unique opportunity to blend deep QMS expertise with cutting-edge digital solutions in a dynamic, fast-paced pharmaceutical environment.
• • You will be at the forefront of ensuring GxP compliance through robust digital systems, directly impacting the quality and accessibility of life-saving medicines.
• • The role requires a strategic mindset to anticipate future needs and proactively implement solutions that support BeiGene's growth and innovation.
• • You will be empowered to make significant contributions to the efficiency and effectiveness of our Quality operations through thoughtful system design and implementation.
• • Your work will directly support BeiGene's commitment to bringing affordable medicines to patients worldwide.