Quality Compliance Associate Director @ Global Biopharma Leader

求人詳細

Lead and grow a team, build cutting-edge quality systems, and develop your expertise in a dynamic global biopharmaceutical company.

About the company
Our client is a leading global biopharmaceutical company dedicated to developing innovative treatments for rare diseases. They foster a collaborative and supportive work environment with a strong commitment to both employee growth and patient care. Their Japan-based team is crucial to their global success.

Role & Responsibilities
You will be a key leader in ensuring the highest standards of regulatory compliance and quality across multiple disciplines within the organization. You'll lead a team of quality professionals, collaborating closely with global counterparts to implement and improve quality assurance systems. You will drive change management initiatives and play a critical role in ensuring compliance with global and local GxP guidelines. This is a fantastic opportunity to develop your leadership and technical expertise within a leading global biopharma company.

Main tasks include
- Lead the development and implementation of quality assurance systems and procedures.
- Manage and mentor a team of quality professionals.
- Collaborate with global teams on regulatory compliance and quality initiatives.
- Drive change management processes and ensure adherence to GxP guidelines.
- Develop and maintain quality agreements with contract manufacturing organizations (CMOs).
- Manage and optimize the quality budget.

If you are interested in this exciting opportunity, apply now.
We look forward to hearing from you.

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こんな方を求めています

経験・スキル

Requirements
- Minimum of 5 years of experience in GQP/GMP in the pharmaceutical industry.
- Experience in drafting and negotiating Quality Agreements (QAGs) with CMOs.
- Proven experience in leading and mentoring teams.
- Strong understanding of Japanese and global pharmaceutical regulations.
- Expert knowledge of GQP/GMP principles and practices.
- Excellent communication and collaboration skills in both Japanese and English.
- Bachelor's degree in pharmacy or a related scientific field.
- Experience with biological products is highly preferred.
- Ability to work effectively in a dynamic and fast-paced environment.
- Strong leadership and decision-making skills.

学歴

大学卒業以上

募集要項

職種

品質マネージャー, ディレクター, ヘッド

給与

年収 1,200 〜 1,600万円

賞与

-

雇用形態

正社員

雇用期間

期間の定めなし

就業時間

09:00～18:00

休日休暇

土曜日　日曜日　祝日

保険

健康保険　厚生年金保険　雇用保険

受動喫煙防止措置

敷地内禁煙

業種

医療機器・医療品関連

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