广告



(senior) Manager, Gcp Inspection Management, Shanghai

发表 2025-01-21
过期 2025-02-21
ID #2562751181
Free
(senior) Manager, Gcp Inspection Management, Shanghai
China, 上海, 上海,
发表 January 21, 2025

描述

Job Description: General Description: The Senior Manager/ Manager, GCP Inspection Management is responsible for implementing and maintaining a balanced, proactive, and phase appropriate approach to GCP Quality Assurance.

This position will beprimarily responsible for ensuring research and development activities are conducted in accordancewith applicable regulatory requirements, guidelines, laws and internally established standards andpractices.

Also responsible for the organization, planning, process and logistics of all health authority inspections.

Essential Functions of the job: Manage and oversee the GCP Quality Assurance activities: Conduct and/or oversee the quality assurance (QA) inspection readiness activities related to FDA and ROW regulations across therapeutic areas and provide GCP guidance for all phases of drug development Support and manage the inspection readiness activities and participate in managing regulatory health authority inspections.

Develop/improve and manage quality systems and processes to include: Creation/revision of appropriate SOPs Implementation and maintaining key QA systems, such as; investigations, Significant Quality Events (SQEs), Deviations, CAPAs, Audits, developing and managing integrated Quality Management Risk plans.

Supporting the activities related to the vendor management process training, SOPs, etc.

Supporting/managing pre-inspection visits at both investigator sites and vendors.

Conducting/managing review of key documents such as study protocols, informed consent documents, Investigator brochures, Clinical study reports, submission modules, etc.

Defining metrics and measures for GCP Quality Assurance to drive assessment and continuous improvement Management and review of trends and report significant investigation/deviation issues and system deficiencies to senior management, as appropriate Support and manage GCP Quality investigations Coordinate and/or administer GCP training, as needed Facilitate and manage inspection readiness meetings and represent Clinical Quality in meetings and discussions as needed Develop a Managing Regulatory Inspections training program for the company and provide training on a periodic and as-needed basis Participate in the review of study related metrics (i.e; protocol deviation, etc.) as part of Quality Management Risk approach to identify gaps, trends and the need for process improvements.

Promote continuous improvement Expert knowledge of GCPs particularly FDA and ICH requirements Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors Ensure follow-up on all inspection commitments, responses, post-inspection activities, corrective and preventative actions, and resolve all issues for timely closure Participate in vendor audits in accordance with Bei Gene standard operation procedures, quality policies and/or plans Create a central repository of all global/local regulatory inspection requirements and practices Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.

Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance Proven ability in setting strategy for and driving quality process improvement initiatives Strong leadership experience and mentoring skills Strong global knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance operations Ensure all logistics are arranged for any Health Authority inspection (remote or on-site).

Other duties as assigned Qualification Required: Bachelor’s degree, preferably in Science Communication and Interpersonal Skills Excellent verbal and written communication skills Ability to effectively collaborate in a dynamic environment ASQ certification is preferred Significant Contacts Quality Assurance Clinical Operations Pharmacovigilance Clinical Business Operations Biometrics Medical Monitors Regulatory Affairs Interacts with all levels of Bei Gene Travel: May require up to 20% travel What We Offer To Our Valued Employees Market competitive compensation package including performance-based annual bonus scheme Company shares (generous welcome grant and performance-based annual equity plan!)In-house and external learning and development opportunities Fantastic benefits program and keep improving!Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.

Join us and Make momentum in your career!Bei Gene 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 Bei Gene is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) Bei Gene’s Job

职位详情

工作类型: 全职
合同类型: 永恒的
薪酬类型: 每月
职业: (senior) manager, gcp inspection management

⇐ 之前的工作

下一份工作 ⇒     

 

联系雇主

    快速搜索:

    地点

    输入城市或地区

    关键词


    广告