Senior Director, QMS Process Owner – Validation & Manufacturing

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

Senior Director, Business Process Owner (BPO) for GxP processes, with a specific focus on Validation and select Manufacturing processes within the Quality Management System (QMS) will be accountable for the global design, implementation, and continuous improvement of these critical processes. You will serve as the subject matter expert (SME) and strategic leader driving compliance, efficiency, and a culture of quality throughout the enterprise. This role ensures QMS processes are aligned with international regulatory standards (e.g., FDA, EMA, ISO 13485, ICH Q10 / E6) and business objectives.
 

Essential Functions of the job:

• Own the Validation and Manufacturing-related QMS processes, ensuring their effectiveness, integration, and compliance across global operations.

• Lead the design, implementation, maintenance, and continuous improvement of validation and manufacturing process elements in the QMS.

• Define and maintain clear process documentation, including procedures, templates, and work instructions.

• Demonstrate technical expertise for assigned processes, staying up-to-date of new approaches & practices

• Establish and monitor KPIs and metrics to evaluate process performance and compliance.

• Guide CAPA investigations related to validation and manufacturing activities and ensure robust root cause analyses.

• Actively lead cross-functional collaboration, promoting seamless integration of QMS processes across business units.

• Deliver training programs to build global process knowledge and capabilities.

• Represent your process areas during regulatory audits, inspections, and management reviews.

• Identify and drive opportunities for digital transformation, automation, and efficiency within the QMS.

• Establish and manage a user community focused on validation and manufacturing QMS processes to foster knowledge-sharing and best practices.

• Perform other responsibilities as assigned.

Supervisory Responsibilities:  

•  NA
   

Skills and Qualifications:   

• Advanced degree in life sciences, engineering, quality management, or related field

• 12+ years of progressive leadership experience in quality management within a regulated industry (pharmaceutical, biotechnology, or medical devices).

• Proven experience with QMS implementation and process ownership.

• Deep expertise with Valiation (equipment, process, cleaning, etc) and Manufacturing processes within the GxP/QMS framework.

• Deep understanding of quality management principles, regulatory frameworks, and industry standards (e.g., ISO 13485, ICH Q10 and E6).

• Excellent communication, negotiation, and stakeholder management skills.

• Strong analytical and problem-solving 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

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene, Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer and we value diversity. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.