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  1. 日本語を使って働きたい人のための求人サイト
  2. 東京 で仕事を探す
  3. Associate Director, Japan Quality & Compliance

Associate Director, Japan Quality & Compliance

1000 〜 1500 万円

  • RGF HR Agent
  • 勤務地: 東京
  • 日本語レベル:流暢に話せるレベル │実務経験:未分類
  • 掲載終了
掲載期間:2019/12/04~2020/06/01

仕事概要

職種 技術職(販売、設計、開発、生産管理)/生産管理、品質管理、施工管理、EHS、PMS
業種 医療/ その他医療
雇用形態 未分類
ポジションレベル その他
募集人数 1名
希望入社時期 -
必須語学力

日本語 (流暢に話せるレベル)

英語 (ビジネスレベル)

活かせる語学 -
勤務時間 その他
福利厚生・休暇
ビザ取得支援 -
外国人従業員 -

仕事詳細

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.

面接について

連絡先

日本東京 地図



担当者名:

Associate Director, Japan Quality & Compliance

RGF HR Agent

1000 〜 1500 万円

掲載終了

会社概要

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

RGF HR Agent

人材、教育、コンサル、専門サービス /人材紹介、求人広告

RGFは、Recruit Global Family日本最大の人材総合サービス/情報提供会社である(株)リクルートホールディングスの海外事業会社として、リクルートが創業以来50年以上に渡り、日本で培ってきたノウハウ、ネットワークを基盤に、国境を超え、グローバルに、あらたな出会いと可能性を繋いで参ります。RGF HR Agentは、RGFの基幹人材ビジネス部門であり、総合HRサービス会社として求人企業の採用活動の支援、求職者の就職活動の支援を強力にサポートいたします。通常のご採用のみならず、RPO(Recruitment Process Outsourcing)、コントラクトなどにも幅広く対応。日本国内で、人材紹介事業、人材派遣事業、求人広告事業
すべての分野でNo.1の実績を誇るRECRUIT=RGFであればこそ実現可能な総合型サービスを、
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