Associate Director, QMS Process Improvement and Analytics

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:

General Description: The Associate Director, QMS Process Improvement and Analytics plays a key role in the oversight, improvement, and execution of BeOne’s Quality Management System (QMS). Reporting to the Senior Director, QMS Process Oversight and Performance, this role helps lead initiatives to strengthen QMS process performance, enhance compliance, and improve usability across the organization.

This position partners closely with QMS Business Process Owners (BPOs), Global Quality, and business teams to drive continuous improvement, digital transformation, and operational excellence in key quality processes such as Deviation Management, Complaint Handling, Change Control, CAPA, Training, Document Management, GxP Surveillance, and Management Review.

Essential Functions of the Job:

• Support the implementation and maintenance of efficient, effective, and compliant QMS processes that align with BeOne’s quality and business objectives.

• Collaborate with the QMS Process Oversight and Performance Management team and BPOs to define, track, and analyze key performance indicators (KPIs), identify trends, and recommend actions to enhance process performance.

• Support Quality Council, Management Review, and other governance meetings by ensuring KPIs, clear summaries of process performance, and effective communication of risks, trends, and required actions.

• Contribute to digital transformation initiatives by supporting the implementation of tools, automation, and analytics that modernize QMS processes and improve data visibility and system performance.

• Collaborate with process owners and governance teams to review and enhance QMS policies and enterprise SOPs, ensuring clarity, consistency, and compliance with regulatory expectations.

• Partner with functional teams to improve the technical accuracy and clarity of documentation within Deviations, Complaints, Change Controls, and other QMS records, providing guidance on root cause analysis and compliant documentation practices.

• Lead or contribute to cross-functional improvement projects to streamline QMS workflows, enhance user experience, and improve right-first-time execution of quality records.

• Support internal and external audit and inspection readiness by ensuring QMS documentation and records are complete, current, and easily accessible.

• Work cross-functionally with Quality, Technical Operations, Regulatory, and other business partners to promote alignment and continuous improvement across QMS processes.

Education and Experience Required:

• ​Bachelor’s degree and 8+ years of progressive quality leadership experience required

• Master’s degree and 6+ years of progressive quality leadership experience preferred

Supervisory Responsibilities:  

• 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.  

• Managerial responsibilities may include matrix reporting, oversight of contingent workers and/or direct reports.

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

• Experience with electronic QMS systems (e.g., Veeva, TrackWise) and understanding of digital quality tools and data analytics.

• Advanced user of Smartsheet for project tracking, reporting, and collaboration.

• Ability to quickly learn and adopt new digital systems supporting QMS and enterprise quality initiatives.

Other Qualifications:

• 8+ years of experience in Quality Systems or Quality Operations within a regulated industry (pharmaceutical, biotechnology, or medical device).

• Strong working knowledge of global regulatory requirements (FDA, EMA, ICH Q10, ISO 9001/13485).

• Hands-on experience with QMS processes such as Deviation Management, Complaint Handling, Change Control, CAPA, Training, Document Management, GxP Surveillance, and Management Review.

• Demonstrated ability to lead or support process improvement and system enhancement initiatives.

• Excellent technical writing and document review skills.

• Strong analytical, problem-solving, and communication skills.

• Proven ability to collaborate effectively in a cross-functional, matrixed environment.

• Certification or training in Lean, Six Sigma, or similar process improvement methodology is a plus.

Travel:  Up to 10%

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 BeOne Medicines 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. 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].