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Method Validation Delivery Manager(PM)
2-3万·13薪
人 · 本科 · 5-7年工作经验 · 性别不限2025/03/11发布
五险一金弹性工作年终奖金定期体检专业培训

浦东新区

低价好房出租>>

伽利略路338号9号楼

公司信息
徕博科医药研发(上海)有限公司

外资(非欧美)/1000-5000人

该公司所有职位
职位描述
I.Job Summary:
This Method Validation Delivery Manager is key to driving execution of New assay validations reporting to the Department Head or Delegate within Scientific Affairs. The Method Validation Office Delivery Manager will work with an established phase gate Method Validation process to ensure programs meet schedule, quality, scope, and targets. The Method Validation Delivery Manager is able to lead and work collaboratively with the Method Validation Core Team members from various functions to successfully drive new assay validations to production under aggressive timelines. The Method Validation Delivery Manager must be able to work independently, handle multiple assay validation projects in parallel, and communicate effectively with all levels of the organization.
Detailed job duties:
Provides oversight and drives the day to day operational and tactical aspects of Method Validation Office Projects assigned including but not limited to
1. Ensure successful execution of program plans, track, manage and communicate progress against contract targets to team and stakeholders
2. Lead daily meetings for high priority program deliverables
3. Track, manage and communicate plan changes to team and stakeholders
4. Work effectively with stakeholders to ensure Method Validation Office goals are in alignment with business objectives
5. Interface with internal/external customers to ensure Method Validation Office activities are completed on time and meet performance goals
6. Translate detailed technical information into high level dashboards and review content
7. Report to Management regularly on Method Validation Office delivery and activities status
8. Participate in interactions with internal and external customers (as needed); lead meetings and record meeting minutes to support Method Validation activities and create alignment on critical deliverables
9. Use project management techniques to identify, develop, and maintain planning tools (e.g. spreadsheets, MS Teams, MS Project) in support of Method Validation project in order to facilitate statements of work and project plans.
10. Maintain all relevant Method Validation project documentation, such as project plans, timelines, presentations, status reports, etc.
11. Communicates effectively and consistently in writing and verbally with all levels of staff and clients
12. Monitors schedule and progress for method validation activities as related to new assays and client related projects.
13. Review and summarize process, conduct trend analysis, provide feedback and recommendation in assisting the timely resolution of issues.
14. Works collaboratively with other departments such as to meet Method Validation Office goals.
15. Contribute to continuous improvements within the Method Validation Office process to improve communication and increase customer satisfaction.
16. Other duties as assigned
II. Experience:
Minimum Required:
Minimum of a Bachelors degree or country equivalent
Ability to manage a minimum of two projects at one time
Strong motivational leadership skills and the ability to influence others without direct authority.
Education may be substituted for experience
Excellent communication, presentation, and interpersonal skills
Proven ability to prioritize and manage time effectively
Demonstrated ability to organize complex and interconnected tasks across a variety of projects
Excellent attention to detail
Able to utilize word processing, database, spreadsheet, and specialized software, extensive experience and skill with the Microsoft Office suite of software is preferred
Able to manage and grow internal and external customer relationships
ISO and FDA regulated environment experience
Fluent in English
III. Education/Qualifications/Certifications and Licenses
Recommended:
Bachelor of Science (BS) or higher in a related area of study
Experience may be substituted for education

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