募集要項
- 募集背景
- An international biopharmaceutical company is looking for an Associate Director, In Market Quality. The selected candidate will provide oversight and strategic guidance for QA operations.
- 仕事内容
-
An international biopharmaceutical company is looking for an Associate Director, In Market Quality.Responsibilities:
* Lead QA department operationally and technically
* Develop and maintain processes for quality activities
* Offer expertise in quality standards and regulations
* Coach and develop team members
* Lead development discussions with direct reports
* Ensure team performance meets expectations
* Contribute to team hiring and management
* Ensure compliance with quality assurance procedures
* Establish agreements with manufacturers
* Ensure compliance with regulations and marketing authorisation
Requirements:
* Bachelor's degree or equivalent in microbiology, biotechnology, chemistry, or a relevant technical domain
* More than 15 years of biopharmaceutical experience (quality, compliance, or regulatory setting)
* Experience in teams or people management
* Understanding of Biologics CMC, GQP, GMP and Japan pharmaceutical-related laws and regulations
* Familiarity with GMP compliance inspection for JNDA
* Proficient in spoken and written English
- 応募資格
-
- 必須
- More than 15 years of biopharmaceutical experience (quality, compliance, or regulatory setting)
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY14,000,000.00 - JPY18,000,000.00 per annum
- 休日休暇
- weekends off, public holidays, paid holidays
