Senior Director, QMS Process Oversight and Performance Management

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 BeiGene’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 :

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.