Job Description

**General Description** : The Senior Director, QMS Process Oversight and Performance is responsible for the strategic oversight, leadership, and continuous improvement of the Quality Management System (QMS). This role involves managing a team of cross-functional QMS Process Owners, driving organizational alignment, and ensuring that QMS processes meet regulatory requirements and business needs. The Senior Director plays a pivotal role in embedding a culture of quality excellence across the organization, ensuring that BeOne's commitment to **"Quality by Everyone for Everyone"** is consistently delivered. **Essential Functions of the job:** + Develop and execute a strategic vision (QMS processes framework) for the QMS processes aligned with organizational goals and regulatory requirements. + Lead the implementation of a harmonized, efficient, and effective QMS across all business units and geographies. + Serve as a senior advisor on quality matters, influencing executive decision-making. + Lead a team of cross-functional QMS Process Owners, fostering a culture of collaboration and continuous improvement. + Ensure effective implementation of QMS processes, such as Change Control, Deviations Management, Document Management, GxP Training, CAPA, and others. + Oversee the development, maintenance, and optimization of QMS policies, procedures, and templates. + Drive process standardization and integration across functional areas. + Ensure that all QMS processes comply with applicable global regulatory requirements (e.g., FDA, EMA, ISO 9001, ICH Q10). + Lead preparation and response activities for internal and external audits and regulatory inspections. + ·Establish and monitor QMS performance metrics to ensure process effectiveness and compliance. + Lead cross-functional initiatives to identify and implement process improvements. + Foster a culture of innovation and proactive problem-solving within the QMS team. + Act as a liaison between the QMS team and other departments to ensure alignment of quality processes with business operations. + Communicate QMS processes strategies, updates, and key metrics to senior leadership and other stakeholders. + ·Represent QMS in executive meetings, management reviews, and quality councils. + Perform other responsibilities as assigned. **Supervisory Responsibilities:** + Ensure leadership, guidance and development opportunities for direct reports **Skills and Qualifications:** + Bachelors degree with 12+ years, Advanced Degree with 8+ years, or PhD/PharmD/MD with 6+ years of progressive leadership experience in quality management within a regulated industry (pharmaceutical, biotechnology, or medical devices). + Advanced degree in life sciences, quality management, or related field preferred + Proven track record in managing global QMS implementation and continuous improvement initiatives. + Experience in leading and developing high-performing teams. + Deep understanding of quality management principles, regulatory frameworks, and industry standards (e.g., ISO 13485, ICH Q10). + Expertise in managing core QMS processes such as CAPA, change control, and deviation management. + Excellent communication, negotiation, and stakeholder management skills. + Proficient in data analysis, project management, and quality improvement methodologies (e.g., Lean, Six Sigma).Ability to communicate complex information clearly and effectively across business functions **Travel:** up to 20% internationally All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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