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**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.