Site Quality Lead - 製薬会社

勤務地 埼玉県
雇用形態 正社員
給与 ¥15000000.00 - ¥20000000.00 (年収)
専門 ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産),
職種 品質管理 / 品質保証,
お問合せ Yoshiko Kumakura
JOB ID JO-2206-471857

MANDATORY

  • Applicants must have permission to work in Japan

  • Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)

☑Foreign business
☑English language required
☑Japanese language required

[Position]
Site Quality Lead

[Company Description]
外資系製薬会社

  • 100ヶ国以上で事業を展開し、トップクラスの売上を誇る世界的企業

[Responsibilities]
As site Quality lead, you will be responsible for leading site quality activities and behavior, establishing quality management system and ensuring it's operated effectively, to ensure the product quality and site operation in accordance with the GMP regulations in Japan & Quality Management System in our Company.

You will be responsible for leading site quality operation's department's routine operation and people management, including quality operations and quality control, supporting site operation ensure the product quality and GMP compliance.

In addition, you will be acting as primary contact of communication between site and external quality units, Japan Quality & Compliance and our Company's global functions. Also along with Certified Pharmacist, you will be the primary contact for local regulatory bodies.

You will be the owner of plant QMS systems-Quality Management.

Skills & Competencies:
Self:

  • Maintaining his / her skills and knowledge on quality systems and regulatory framework up to date and promote a culture of continuous learning.

  • Demonstrates leadership behaviors in alignment with our Company's leadership standards.

  • Develops and updates performance objectives and accomplishments in Workday system and hold discussion on Employee Development Plan (EDP) for key roles in organization aligned with Performance Management Process.

  • Ensures both operational knowledge and technical skills are maintained and compliant with individual training requirements.

Technical Responsibilities:

  • Knowledge in more than one key function area of solid oral dosage manufacturing/packaging operations/Sterile operations (e.g. manufacturing, Technical Operations, Supply Chain, etc.)

  • Knowledge in fields of quality operations, quality management systems, lab systems.

  • Knowledge on Japan regulatory requirements in GMP environment

  • Knowledge on fields of EHS, Operational Excellence, Lean Manufacturing, Continuous Improvement

Business & Leadership Responsibilities:

  • Capacity to be a change agent

  • Displaying high integrity and honesty

  • Capacity to think and act strategically

  • Results driven, resilience

  • Business acumen and understanding of all financial aspects linked to role

  • Problem Solving and Decision-Making skills

  • Planning and Organization skills

  • Written and spoken communication skills in both Japanese & English

  • Ability to motivate group whilst keeping focused on objectives

  • Ability to act as coach and mentor

  • Continuous Learning

[Requirements]
Education:

  • Master's degree in pharmacy, Chemistry, Chemical Engineering or equivalent degree.

Experience:

  • 12 years of pharmaceutical experience with a minimum of 5 years of quality operations, manufacturing, packaging supervisory management experience with increasing levels of responsibility; experience in more than one functional area.

Specific Knowledge:

  • Regulatory & Quality Management Systems, Pharmaceutical Processing, Effective communication skills, Talent development and Organizational design skills, Good English & Japanese Knowledge, Continuous process improvement, Problem solving capability

[Language Requirement]

  • English Language level: Business level

  • Japanese Language level: Fluent - Native Level (Equivalent to JLPT N1)

  • Work permission in Japan required

[Salary]
15〜20 million JPY
※Experiences and skills will be considered

Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.

Reference: JO-2206-471857
#LI-Remote
Seniority Level: Mid-Senior level
Job Function: Quality Assurance