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  3. Associate Director, Japan Quality & Compliance

Associate Director, Japan Quality & Compliance

1000 〜 1500 ten thousand JPY

  • RGF HR Agent
  • Location: Tokyo
  • Japanese level:Fluent │Required length of experience:Uncategorized
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Date:2019/12/04~2020/06/01

Job summary

Job category Technical (Sales / Design / Development / Production Control)/Production Control / Quality Control / Construction Control / Environment, Health, and Safety / Postmarketing Surveillance
Industry Health Care/ Other Health Care
Employment type Uncategorized
Position level Other
Number of openings 1
Desired entry time -
Required language skill

Japanese (Fluent)

English (Business)

Foreign language competence -
Working hours Others
Welfares / Leave systems
Assistance in visa application -
Number of foreign employees -

Work details

Company Overview
Associate Director, Japan Quality & Compliance - Top Global Pharma Company

Job Description
Responsibilities:

1. Responsible to implement Quality Assurance policy and discharge QA responsibilities (deviation management, change control, market release, complaint handling, training, audits, self-inspections, etc.) in alignment with the GQP regulations in conjunction with and under the direction of the Director (GQP Quality Assurance Supervisor).

2. People manager to a team of quality professionals, supporting routine work activities, managing priorities, and career development. Will exercise a leadership role in managing and inspiring an effective team.

3. Assures the team operates within established policies and procedures of the Division and Corporation and complies with all applicable governmental regulations (GQP, Corporate / Divisional Policies / Procedures, etc.).

4. Assures that products are produced from approved processes in conformance to all applicable regulatory requirements and Company Policies.

5. Build and maintain effective Quality Systems and proactively drive continuous improvement. Exercise analytical and scientific skills to manage activities necessary to support the Quality Systems program for the manufacturing, testing, packaging, storage, and distribution of API intermediates, API, non-sterile pharmaceutical products, sterile pharmaceutical products, vaccines, biologics.

6. Participate in strategic initiatives for compliant supply, operationalizing quality, and developing an engaged and capable workforce.

7. Act as an interface on the Company’s behalf with regulatory agencies.

8. Manage and drive resolution of quality issues and support effective issue management with Global counterparts.

9. Coordinates significant investigations including product recalls as needed.

10. Closely collaborates, builds and maintains strong relationships with stakeholders both internal and external.

11. Ensures the quality performance of external parties through direct oversight, support and technical advice, and providing on-site supervision as appropriate.

12. Supports Alliance Management and Business Development projects, overseeing activities such as external party selection (GMP Due Diligence), commercialization, and establishing Quality Agreements.

13. Supports various risk management assessments at external parties such as data integrity and Quality Risk Management (QRM).

Requirements
Qualification / Skills:

- BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) preferred.

- Knowledge / Expertise in API, non-sterile / sterile products, vaccines, biologics manufacturing processes and quality systems.

- Must have strong knowledge of and broad experience in Quality Assurance and Quality Control activities. Minimum of 8 years’ experience in the pharmaceutical industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of GQP, GMP and regulatory requirements.

- Current or prior experience as a people manager or team leader.

- Must have very strong English speaking, listening, and written skills. Can independently lead discussions and drive issue resolution with Global counterparts.

- Competent in analyzing complex product, production, testing, and regulatory issues and have demonstrated scientific problem-solving capabilities.

- Possesses a strong compliance mindset.

- Must have strong demonstrated interpersonal skills, including leadership and coaching, motivation, strategic communication and negotiation.

- Some level of contractual and financial awareness is required.

About interview

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Name of person in charge of hiring:

Associate Director, Japan Quality & Compliance

RGF HR Agent

1000 〜 1500 ten thousand JPY

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Company overview

RGF HR Agent Associate Director, Japan Quality & Compliance RGF HR Agent Associate Director, Japan Quality & Compliance

RGF HR Agent

Human Resources / Education / Consulting / Professional Services /Staffing / Recruiting

RGF (Recruit Global Family) is the overseas corporation of Recruit Holdings Co., Ltd., Japan's largest talent comprehensive service and information service group enterprise, has started for more than 50 years, based on excellent business philosophy and management experience. Transcend national borders, we will discover new opportunities and possibilities worldwide.
RGF HR Agent provides solid support for the hiring activities of companies and the job-hunting activities of applicants as a general HR service company.
We provide not only regular recruitment but also RPO (Recruitment Process Outsourcing), contracts and so on. We deliver comprehensive services that could only be offered by RECRUIT=RGF, which is number one in Japan in the field of talent introduction, temporary staffing and recruitment information advertising. Having thoroughly met the needs of leading companies in Japan, we will also provide our consummate, high-quality services overseas. RECRUIT=RGF, which is number one in Japan, will continue taking on the challenge of becoming number one in the world.

JAPAN: RGF HR Agent Japan (CDS)
Address: 東京都渋谷区広尾1-13-7恵比寿イーストビル2F
TEL (+81)3-6422-4400
Website: http://www.rgf-hragent.asia/en/japan

CHINA: RGF HR Agent (Shanghai)
Address: 上海市淮海中路8号 蘭生大厦9F
TEL (+86) 21 5331 8000
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Suzhou)
Address: 蘇州市工業園区蘇州大道西1号 世紀金融大厦1615室
TEL (+86) 512 6262 3595
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Beijing)
Address: 北京市朝陽区東三環中路39号建外SOHO,A座902室
TEL (+86) 10 5869 0121
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Tianjin)
Address: 天津市和平区南京路189号津汇広場一号楼1106单元
TEL (+86) 22 2331 1169
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Dalian)
Address: 大连市高新技术产业园区黄浦路537号(七贤路)泰德大厦811室
TEL (+86) 411 8445 7095
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Guangzhou)
Address: 广州市天河区林和西路161号 中泰国际广场A塔1309室
TEL (+86) 20 8527 4585
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Shenzhen)
Address: 深圳市罗湖区嘉宾路2018号深华商业大厦2507室
TEL (+86) 755 8237 5208
Website: http://www.rgf-hragent.asia/china

HONGKONG: RGF HR Agent Hong Kong Limited
Address: Unit 2206, 22/F, Wu Chung House, 213 Queen’s Road East, Wan Chai, Hong Kong
TEL (+852) 2537 2557
Website: http://www.rgf-hragent.asia/en/hongkong

VIETNAM: RGF HR Agent Vietnam Co., Ltd.
Address: RM903 Central Plaza 17 Le Duan St., Dist 1 Ho Chi Minh City
TEL (+84) 8 3911 5800
Website: http://www.rgf-hragent.asia/en/vietnam

THAILAND: RGF HR Agent Recruitment (Thailand) Co., Ltd.
Address: 689 BHIRAJ TOWER at EmQuartier, 23rd Floor, Room No. 2304-2306 Sukhumvit Road, North Klongton Sub-District, Vadhana District, Bangkok 10110
TEL (+66)2-021-0333
Website: http://www.rgf-hragent.asia/thailand/

SINGAPORE: RGF HR Agent Singapore Pte. Ltd.
Address: 71 Robinson Road #05-04 Singapore 068895
TEL (+65) 6221 7437
Website: http://www.rgf-hr.com.sg/

INDIA: RGF Select India Private Limited
Address: 704-705-706, 7th Floor, Vatika City Point, MGRoad, Gurgaon 122002
TEL (+91)124 4139711
Website: http://www.rgf-hragent.asia/en/india

INDONESIA: PT. RGF Human Resources Agent Indonesia
Address: Jakarta Office: Graha Pratama, P1F (21F), Jl. M.T.Haryono Kav. 15, Jakarta 12810, Indonesia
TEL (+62) 21 8378 2866
Website: http://www.rgf-hragent.asia/en/indonesia

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