Senior Director, QMS Process Oversight and Performance Management

BeiGene, Ltd.; United States; Remote; USD 197,000 - 268,000; Full time

Job summary

BeOne Medicines is seeking a Senior Director for QMS Process Oversight and Performance Management. The role will focus on strategic leadership of the Quality Management System, ensuring compliance with regulatory requirements, and driving continuous improvement within the organization. Candidates should have extensive experience in quality management, leading teams, and embedding a culture of quality excellence.

Benefits

Medical, Dental, Vision coverage

401(k) with company match

Paid Time Off

Wellness programs

Equity participation

Qualifications

• Progressive leadership experience in quality management.
• Managing global QMS implementation and continuous improvement.
• Proficient in quality improvement methodologies like Lean and Six Sigma.

Responsibilities

• Develop strategic vision for QMS processes aligned with goals.
• Lead implementation of efficient QMS across business units.
• Communicate QMS strategies and metrics to senior leadership.

Skills

Leadership

Communication

Data Analysis

Project Management

Collaboration

Problem Solving

Education

Bachelor's degree with 12+ years experience

Advanced degree in life sciences preferred

PhD/PharmD/MD with 6+ years experience

Job description

Senior Director, QMS Process Oversight and Performance Management page is loaded

Senior Director, QMS Process Oversight and Performance Management

Apply locations Remote (US) time type Full time posted on Posted 30+ Days Ago job requisition id R28157

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:

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

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

Salary Range: $197,500.00 - $267,500.00 annually

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.

Similar Jobs (5)

Director, BPO for Deviations, Complaints and CAPA

locations Remote (US) time type Full time posted on Posted 27 Days Ago

Associate Director, Digital Quality Management Systems Operations and User Experience

locations Remote (US) time type Full time posted on Posted 3 Days Ago

Associate Director, Supply Chain - CMO Management & Project Management

locations Remote (US) time type Full time posted on Posted 12 Days Ago

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more aboutBeOne, please visitwww.beigene.com and follow us onLinkedIn ,X (formerly known as Twitter),Facebook andInstagram .

To Mainland China Candidates

For more information, please visit the link to explore job opportunities in China Mainland.

At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things.