Sr. Specialist / Manager, QMS Operations

Beigene, Ltd. San Mateo , CA 94401

Posted 2 months ago

General Description:

This position is responsible for providing operational support for all operations within Quality Management Systems (QMS) department, such as Quality Training, DocControl, Quality Management System, Inspection Management, and the Lab Information Management System (LIMS). Providing day-to-day support to serve as staff augmentation, backup during peak workload periods, and during systems implementations/upgrades/maintenances. This individual should be passionate about helping QMS team members and is knowledgeable across all functions within QMS department.

Essential Functions of the job:

  • Work cross-functionally to support the development and update of policies and procedures in support of BeiGene's Quality Systems

  • Provide operational support for all operations within the Quality Management Systems (QMS) department

  • Provide day-to-day support and serve as staff augmentation, backup during peak workload periods, and during systems implementations/upgrades/maintenances

  • Support testing and training activities as needed for QMS project implementations

  • Support the execution of Quality Quarterly and Annual Reports

  • Serve as the utility person within the QMS department

  • Other duties as assigned

Supervisory Responsibilities:

  • May manage Quality staff and provide coaching, and support development plans

Competencies:

Ethics

  • Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing

  • Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication

  • Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork

  • Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

Adaptability Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills

  • Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability

  • Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality

  • Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical

  • Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving

  • Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management

  • Communicates changes and progress; Completes projects on time and budget.

Computer Skills:

  • PC literate with MS Office skills (Project Plan, PowerPoint, Outlook, Word, Excel, Visio)
  • Strong application knowledge of Veeva QualityDocs, Veeva QMS, ComplianceWire, LIMS and other QMS applications.

Other Qualifications:

Education Required:

Bachelor's degree in science or combination of education and equivalent work experience

  • Understanding of Quality best practices, including familiarity with Quality Systems Regulations, GxPs, and applicable ISO Standards

  • Strong Presentation Skills

  • Leadership Skills

  • Experienced working cross-functions with Quality Management Systems

  • Experienced interfacing with external software vendors

  • Strong knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs)

  • Strong presentation & communication skills

  • Ability to effectively collaborate in a fast pace dynamic environment

Travel:

  • As required

#LI-KC1


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Sr. Specialist / Manager, QMS Operations

Beigene, Ltd.