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Clinical Study Unit Quality Lead (CSU QL)

사노피아벤티스코리아

http://www.sanofi-ave..

관심기업

프랑스에 본사를 둔 사노피 그룹은 세계 선두의 헬스케어 기업입니다. 국내에서는 사노피-아벤티스 코리아가 전문의약품 및 건강기능식품(세노비스)을 공급하고 있..  

업종 병원/제약/복지 자본금 27억9000만
기업형태 일반기업 매출현황 3723억2000만
대표자 배경은 사원수 535 명
회사주소 서울 서초구 반포동 235
  • 현재 채용정보를 복사합니다.
  • 현재 채용정보를 프린팅합니다.
직종 생산관리·품질관리·품질보증, 제약·의약
키워드 품질, 제약
근무형태 정규직 채용직급 면접후 결정
모집인원 0 명 나이 -
경력 경력 5년 이상 급여조건 당사규정
학력 대졸 이상 접수기간 2020.05.17 ~ 2020.06.14
 [홈페이지접수]

2020년 6월 14일 (일) D-11 전입니다.


Clinical Study Unit Quality Lead (CSU QL)

모집부문 및 자격요건

상세내용 

RESPONSIBILITIES:

Ensure CSU alignment and compliance to the sanofi R&D quality system and related clinical operation activities within the Sanofi Group.

Work collaboration: With the respective Country Quality Head (CQH) at country level to ensure, local clinical trial related activities are managed as per the expectations within the Global Quality System and R&D level.

The CSU QL Manager depends on local organization. The CSU QL is a member of the CSU Quality Network

 


KEY ACCOUNTABILITIES:

1. At global level (global role)

The CSU QL is actively interacting with Global such as:

- Define and update, in collaboration with Clinical Quality and Continuous

- Improvement (CQCI)/Clinical Quality System (CQS), the scientific and technical training curricula for CSU roles (e.g. Mandatory a n d Recommended trainings on QDs, business tools and regulatory topics)

- Lead/Participate as an active member in the preparation/revision of Global QDs that are related to CSU activities

- Lead/Participate to the preparation of Global training programs that are related to CSU activities (e.g. analysis of needs, training proposal review, development and pilot/test)

- Attend corporate meetings and training sessions

- If qualified perform delegated audit related activities within country and or region (supervised by CQCI)

- As applicable participate on In Process Control (IPC) and GCP-PAI Readiness

- Preparation Team, and coordinate with CSU QL network to ensure inspection readiness (IPC)

- Participating in working groups organized by the CSO platform in relation to all his/her duties as applicable

- Identifying and implementing tools to fulfil his/her duties with other company divisions as applicable,

 

2. At CSU level

The CSU QL is the main contact person for the CSU teams for all quality, process and training aspects. CSU QL should also work closely with the CQH to ensure that CSUrelated activities are appropriately covered in the respective quality systems in all countries part of the CSU.

 

The CSU QL is also responsible to maintain the appropriate qualification (and thereof documentation) of the CSU staff for:

- Corporate & CSU or country/multi-countries (local) QDs

- Good Clinical Practices (GCP)

- International and local regulations

- Study management activities (e.g. mandatory role-based training)

Therefor at the CSU level, the CSU QL should ensure the following:


General duties:

- Acting as the first point of contact for question on GCP Involvement in the definition of quality indicators for the CSU

- Providing quarterly report on corporate defined quality indicators

-To develop, implement and maintain an integrated quality system to achieve compliance with GCPs and regulatory requirements, as well as operational excellence.

- To lead continuous quality and performance improvement through processes optimization and innovation to positively influence productivity/quality/compliance and deliver to customers values derived from such innovations.

- Support all the CSU initiatives in term of quality

 

Training:

- Maintenance of appropriate qualification of the CSU staff following recommended training plans

- Contributing to the training of CSU members when new local quality documents are updated or released (training curricula for CSU roles e.g. mandatory and recommended training on QDs, business tools and regulatory topics),

- Tailor functional training based on needs

- Organizing the initial training programs of new comers and the continuing professional knowledge and skills development of CSU members.

- Delivery of GCP training programs

- Deployment/implementation of global training program at CSU level

- Ensure availability of training records at CSU level

- Perform quality visits for site/CRA assessment and improvement, if needed


QD management:

- Reviewing the QD Letters of the Clinical Sciences & Operations (CSO) platform and corporate processes, analyzing or forwarding to the experts for analysis these

 

documents,

-Distributing QD letter information to the people/entities involved. If necessary, launching the process of revising/updating local quality documents

- Overseeing the follow-up of CSU quality documents and the update of the tracking table. Ensuring the gap analysis versus the global QD list; updating or creating local QD if required,

- Ensuring that local CSU quality documents are filed,

- Making quality documents available to CSU team (Geode+/Gibraltar)

- Organizing the update of the local CSU quality documents when required:

- By global procedures

- By local regulation

- When the documents are obsolete (SOP revised every three years and documents updated)

- Oversight on the use of appropriate QDs by Affiliate Medical Affairs for protocol reparation and timely Clinical Study Report completion (Other studies types)

- For Medical affairs: Key provider of applicable quality documents and reference person to be consulted before any new study initiation and together with CQH ensure that local quality documents applicable to the Medical Managers are correctly implemented.

- Escalation to CQCI/CQS of any relevant GCP and/or regulatory information that would require further action

- Maintenance of an historical file of the CSU and/or country/multi country (local) QDs

- Contributing, when requested, to training study sites (making study quality evaluation)

 

Audit/Inspection duties:

- Preparation and Participation in local audits and GCP inspections

- Involvement in audit performance of CROs working in collaboration with Medical Affaires

- Participation in continuous improvement action/CAPA post audits/post quality reviews and inspections

- Participation in investigations for serious GCP non-compliance/alleged scientific misconduct relevant to their geographic area

 

Service Provider Qualification duties:

- Based on country organization: Oversight of outsourced partners at local affiliate level that are conducting clinical trial related activities on behalf of CSU and/or Medical Affairs to ensure appropriate vendor qualification is in place.

- Based on country organization: Perform local service provider qualification assessments on GCP activities in cooperation with CQH and Procurement,

- Contributing to the training of local vendors involved in clinical activities (training curricula for CRO, mandatory training on QDs, business tools) and supporting CSU CPL for vendor overseeing,

 

3.Transversal interactions

Transversal interaction when needed (e.g. quality topic(s), continuous improvement, training, processes, QD and training)

- At affiliate level: With the respective CQHs of the concerned countries, for topics such as affiliate quality systems managed by the CQH, inspections and GCP audits. If applicable, interactions with other affiliate members such as PV, Regulatory, …

- At CSU level: W ith other stakeholders such as the CSU System Expert, CSU Safety Lead, CTA-RM, CSU Record Specialist and Investigational Product Manager,

- Within the community of CSU QL for collaborative work, sharing experiences and good practices.

- At Global level with stakeholders within CQCI/CQS

- Contributing to topics related to his/her training duties,

 

QUALIFICATIONS

Education:

Degree in life sciences or scientific discipline or equivalent.

Experience & knowledge:

A minimum of 5 years of professional experience in Clinical Development would be necessary.

Core competencies:


As a requirement for her/his mission, the CSU QL should demonstrate:

- Good working knowledge of global and local clinical development processes.

- Adequate knowledge of GCP and relevant Regulations (country, region and international when applicable)

- Robust transversal communication skills to ensure appropriate business interaction with the various global, CSO, CSU departments and functions, and other partners (e.g. CQH)

- Ability to clearly exchange and train in English (oral & written)

- Conscientiousness, responsiveness, organization and planning

- Negotiation skills

- Autonomy, sense of responsibility and reporting skills

- Proficiency in IT tools and change management 

근무조건

  • - 근무형태 : 정규직
  • - 근무지역 : 서울 서초구

전형절차

  • - 서류전형 > 면접전형 > 2차면접 > 임원면접 > 합격자 발표

제출서류

  • - 이력서, 자기소개서 (이력서에 연락처, 희망연봉 기재)

접수기간 및 방법

  • - 접수기간 : 2020.05.17 ~ 2020.06.14까지
  • - 접수방법 : 홈페이지지원(https://sanofi.wd3.myworkdayjobs.com/SanofiCareers/job/Seoul/Clinical-Study-Unit-Quality-Lead--CSU-QL-_R2552874-1)

기타

  • - 병역필 또는 면제자
  • - 해외여행에 결격사유가 없는 자


* 입사지원 시 중요사항을 꼭 체크하세요!

* 근무환경
근무지역 : 서울 > 서초구
급여조건 : 당사규정
* 접수개요

마감 11일전

시작일 : 2020년 5월 17일 (일)
마감일 : 2020년 6월 14일 (일)

접수기간   오늘   마감

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2020. 06

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사노피아벤티스코리아 홈페이지에 직접 접속하여 지원하세요
https://sanofi.wd3.myworkdayjobs.com/SanofiCareer..

* 담당자 정보 - 이름 : 채용담당자
- 홈페이지 : http://www.sanofi-aventis.co.kr/
- 주소 : 서울 서초구 반포동 235
현재 채용정보를 복사합니다. 현재 채용정보를 프린팅합니다.

등록 : 2020년 5월 17일 (일) 19:24    최종수정 : 2020년 5월 17일 (일) 19:24

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