Job Directory Quality Management System Specialist

Quality Management System Specialist
Emeryville, CA

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Job Description

Essential functions of the job:

* Support development, implementation and management of Quality Management System (QMS) and related processes to ensure adherence to regulatory and BeiGene requirements.
* Collaborate with Global Quality Organizations to identify and implement system enhancements.
* Participate in testing and verification of new and revised system functionality/enhancements.
* Enter and update system list of values timely, as needed.
* Support testing and training activities as needed for system implementations and or enhancements.
* Work cross-functionally to support the creation and revision of policies and procedures in support of BeiGene's Quality Systems.
* Manage user change requests and change process.
* Gather user requirements and work with technical personnel to define the appropriate configuration for IT Systems to meet defined business requirement.
* Consult with management and business partners

Other Qualifications:

* Understanding of Quality best practices, including familiarity with Quality Systems Regulations, GxPs, and applicable ISO Standards
* Strong knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs).
* Excellent attention to details
* Ability to effectively manage time and progress tasks to meet timeline in a fast pace/dynamic environment
* Effective oral and written communication skills
* Experienced working cross-department with Quality, IT, Clinical, Regulatory and Development.

* Working knowledge of business process and process improvement
* Experienced interfacing with external software vendors.
* Experienced in managing projects towards process improvements.

Computer Skills:

* PC literate with MS Office skills (Project Plan, PowerPoint, Outlook, Word, Excel, Visio)


* As required


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.


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