Quality Manager
PPD 查看所有职位BeijingUpdate time: July 13,2019
Job Description

PPD is proud to employ over 20,000 employees worldwide, across 47 countries and 89 offices. In just over 30 years, PPD has grown to become a leading U.S. based CRO and recently has won accolades for industry leading CRA team, employee training & development, excellence in service and numerous awards for Best CRO. Our sustained year on year growth means that we are always looking for exceptional clinical talent to join our company.



Since opening in 2007, PPD’s offices in China now include 20 different departments. The combined Beijing and Shanghai offices are now seven times the size they were two years ago and are continuing to grow. In 2018 alone, the Clinical Management team is expected to triple in size. PPD China is able to offer our staff opportunities to collaborate on projects not only in Asia Pacific, but in regions around the world. You’ll have the opportunity to work on multinational trials—with top-tier sponsors, and on an industry-leading platform.


Policy & Strategy


Interprets and administers policies, processes, and procedures that may affect sections and subordinate work units. Acts as advisor to subordinate(s) to meet schedules and / or resolve technical problems. Requires full knowledge of own area of functional responsibility.


Freedom to Act


Assignments are defined in terms of activities and objectives. Work is reviewed


upon completion for meeting timelines, adequacy, and objectives.


Liaison


Interacts frequently with internal personnel and outside representatives at various levels. Participates and may present at meetings with internal and external representatives. Interaction typically concerns resolution of operational and scheduling issues concerning projects and / or contractual clarifications.


Additional / Specific Job Responsibilities:


?Conduct quality visit to identify quality gaps, share observations and recommendation with PM, CTM, CRAs and LMs on project/country/site level;


?Generate Quality Strategy & Training Plan, conduct trend analysis, delivery the quality improvement training to the study team per the quality visits observations. Lead Trainee Training Program delivery.


Provide effective coaching and training to achieve and improve quality needs at project, country and site level.


?Represents operations during onsite audits and/or regulatory inspections.


?Oversee the clinical monitoring compliance metrics’ improvement


任职要求:

Education and Experience:


Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).


2+ years of management responsibility


Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.


Knowledge, Skills and Abilities:


Strong knowledge of PPD SOPs and the drug development process, including current ICH, EU and FDA guidelines and/or requirements. May also require knowledge of USP


Excellent team leadership and management skills, including employee development, team building and resource management


Excellent verbal and written communication and presentation skills


Excellent mentoring, coaching and feedback skills


Ability to think strategically, short and long term planning, and successful execution and delivery of project plans and organizational development


Excellent judgment and independent decision making skills


Strong knowledge of training and development theory, design, and principles of adult learning


Strong knowledge of various programs, including Microsoft Word, Excel and PowerPoint


Strong knowledge of various databases, including Learning Management Systems, Procedural Document Systems, Data Acquisition Systems and Project Management/Scheduling Systems


Ability to recognize and establish process improvement methods on a multi-site scale


Ability to develop training content and meet the diverse needs of a multi-national organization


Exceptional cultural awareness and ability to communicate and train across multi-ethnic/multi-diverse units


职能类别: 总监/部门经理

关键字: *** 培训

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上班地址:东直门南大街1号来福士大厦

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