BeiGene 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:
As the Head of Quality Management Systems, you will be responsible for ensuring the development, implementation, and maintenance of robust quality management systems across all aspects of our operations. You will lead a team of quality professionals and collaborate with cross-functional teams to uphold regulatory compliance, drive continuous improvement initiatives, and foster a culture of quality excellence.
Essential Functions of the job:
Develop and implement strategies to establish and maintain an effective Quality Management System compliant with global regulatory standards (e.g., NMPA, FDA, EMA, ICH etc).
Provide leadership and direction to the QMS team, fostering a culture of accountability, collaboration, and continuous improvement.
Oversee the documentation and control of quality policies, standards, procedures, and processes, ensuring alignment with global regulatory requirements and industry best practices.
Lead internal and external escalation management, ensuring timely resolution of events and implementation of corrective and preventive actions (CAPAs).
Establish a global network of process leads and subject matter experts representing manufacturing sites, global regions and relevant functions that provide leadership in GxP variation and change management, product complaints, all relevant quality processes in line with industry best practice and regulations or guidance such as ICH Q10 and ICH E6.
Act as the business owner for electronic systems that handle documentation, training, deviation/CAPA, complaints etc. Specifically responsible for the eQMS (Veeva) and ensuring its validated state and user satisfaction.
Collaborate with cross-functional teams to ensure quality considerations are integrated into all stages of product development, manufacturing, and distribution.
Drive initiatives to optimize QMS processes, enhance efficiency, and reduce compliance risks using continuous improvement concepts.
Ensure a robust trending program for quality events, lab and production controls to identify adverse trends / risk
Ensure validation (inc Computer Systems Validation (CSV)) processes are fully implemented with appropriate quality oversight.
Ensure QMS readiness and implement processes for new product presentations and processes, e.g. devices, combination products, Antibody-Drug Conjugates (ADC) and Cell and Gene Therapy (CGT)
Stay abreast of emerging regulatory requirements, industry trends, and best practices in quality management, and implement necessary changes to maintain compliance and enhance quality systems.
Serve as a subject matter expert on quality management systems, providing guidance and support to internal stakeholders at all levels of the organization.
Foster a culture of quality excellence in QMS through training, communication, and improvement programs.
Ensure leadership, guidance and development opportunities for direct reports
Other duties as assigned
Supervisory Responsibilities:
This position requires strong cross-cultural and international leadership experience to ensure high performance management, coaching and mentoring of BeiGene staff.
Computer Skills:
Strong PC literacy
Extensive experience with GxP QMS platforms, e.g. Veeva
Other Qualifications:
Bachelor’s or advanced degree in a relevant scientific or engineering discipline
Minimum of 15 years of experience in GMP environment with at least 10 years of Quality Management Systems experience in biological and pharmaceutical industry with progressive leadership responsibilities
Proven track record of successfully leading QMS implementation and optimization
Experience interacting with health authorities during pre-approval and routine site inspections is highly desirable
Experience with R&D, manufacturing and distribution of clinical and commercial products preferable
Experience with global multi-national companies is highly desired
Demonstrated ability to drive a culture of quality with the ability to influence and collaborate across global regions, functions and levels of the organization
Excellent verbal and written communication skills
Cultural dexterity in work environments
Ability to effectively collaborate in a high-paced dynamic environment
Fluent in English, second language desirable, Mandarin proficiency an advantage
Travel:
Up to 20% globally
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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: $203,000.00 - $283,000.00 annually
BeiGene 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.
