Senior Manager/ AD, Quality Systems Development
Emeryville, CA

Job Description

The Sr. Mgr./AD of Quality Systems Development is responsible for day-to-day management of all operations activities within eQMS department as well as improvement of Quality Systems, Quality processes, and refine Quality project management methodology. This individual should be passionate about automating business processes and is knowledgeable on project methodology.

Essential Functions of the job:

* Serve as BPO for Veeva Vault Quality Management System (eQMS)
* Serve as project lead in the implementation of Quality computer systems and related processes.
* Create and utilize project management tools for Quality.
* Provide regular updates to management on project progress and escalate challenges as needed.
* Manage Quality project teams to meet increasing demand for new and updated systems implementation and maintenance.
* Implements and provides guidance related to Quality project processes and policies.
* Oversee the execution of Quality Quarterly and Annual Reports
* Oversee the work of project management resources to ensure the coordination and completion of projects and resolution/escalation of project challenges.
* Work cross-functionally to support the development and update of policies and procedures in support of BeiGene's Quality Systems.
* Train and mentor users on the use of new and updated Quality business process, system, policies and procedures.
* Facilitate the definition of business requirements for Quality Systems.
* Author Quality Systems business processes.
* Work with technical personnel to define the appropriate configuration for IT Systems to meet defined business requirements.
* Support testing and training activities as needed for project implementations.
* Other duties as assigned

Supervisory Responsibilities:

* Manage and mentor employees in VVQMS Team.
* Provide managerial support to one or more contingent workers with overall responsibility of leading, training, and mentoring for effective performance

Computer Skills:

* Intermediate to advance skill in MS Office applications (Project Plan, PowerPoint, Outlook, Word, Excel, Visio)
* Certification in Veeva Vault Quality Suite or similar application is a big plus

Other Qualifications:

* This is a hands-on position with the agility to multitasks while keeping focus.
* In-depth understanding of Project Management best practices, processes and tools.
* Understanding of portfolio management processes
* Understanding of Quality best practices, including familiarity with Quality Systems Regulations, GxPs, and applicable ISO Standards
* Strong Presentation Skills
* Leadership Skills
* Strong project management experience in managing resources towards meeting goals, completing projects and resolving challenges.
* Strong project management experience in leading complex computerized systems projects in the pharmaceutical regulated environment.
* Strong experience presenting to upper management and large audiences.
* Strong experience in implementing and executing project management practices and tools.
* Experienced in managing resources in setting and achieving development goals.
* Experienced in managing projects towards process improvements.
* Experienced working cross-department with Quality, IT, Clinical, Regulatory and Development.
* Experienced interfacing with external software vendors.
* Strong knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs).
* Fluent in Mandarin is a big plus

Travel:

As required

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.

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