qa manager/ life sciences [professional haken]. Job at Randstad, 東京23区

MjFjMkF2NlpVR29KdjBQYmZBK2psUlFUeVE9PQ==
  • Randstad
  • 東京23区

Job Description

社名
社名非公開

職種
品質マネージャー, ディレクター, ヘッド

業務内容
■Work conditions・Temp-to-Perm・Telework possible・Location: Tokyo・Hourly wage: Up to ¥3,000 - 5000 (Annual salary: Up to ¥8 million) ーーーーーーーーーーーーーLead a dynamic team, ensuring top-tier quality in a cutting-edge life sciences environment. ■About the companyOur client is a pioneering life sciences company committed to delivering innovative pharmaceutical solutions. They foster a collaborative and supportive work environment where continuous learning and professional growth are highly valued. They are seeking a highly skilled and experienced QA Manager to join their team.■Role & ResponsibilitiesYou will oversee all aspects of quality assurance, ensuring compliance with Japanese regulatory requirements. You will lead a team, mentor junior staff, and collaborate with cross-functional teams to guarantee the highest quality standards in all processes, from research and development to commercialization. You will play a pivotal role in the company's success.■Main tasks include・Lead preparation of pharmaceutical documents for submission to Japanese regulatory authorities.・Ensure compliance with regulations related to ethical pharmaceuticals, OTC, and regenerative medical products.・Conduct GMP audits of manufacturing sites.・Review QA submission documents, assess change controls, and manage batch release of commercial products.・Oversee QMS, SOPs, vendor audits, and market complaint handling.・Support GMP inspections by PMDA and other relevant authorities.・Manage departmental goals, budgets, and training of subordinates.If you are interested in this exciting opportunity, apply now.We look forward to hearing from you.#LI-Hybrid


求められる経験
■Requirements
・Minimum 10 years of experience in a QA role within the pharmaceutical industry.
・Minimum 3 years of experience as a QA Manager or QC Manager for Type I, Type II, or regenerative medical products.
・University degree or higher in a biological science (medicine, pharmacy, science, agriculture, etc.); doctoral degree preferred.
・Expert knowledge of Japanese pharmaceutical regulations (PMDA and MHLW).
・Proven experience conducting GMP audits and supporting regulatory inspections.
・Experience reviewing manufacturing documents, deviations, change controls, and CAPAs.
・Excellent written and verbal communication skills in English and Japanese.
・Proven ability to lead and manage a team.
・Experience preparing presentations and communicating complex information clearly.
・Strong understanding of QMS, SOP development, and vendor management.

保険
健康保険 厚生年金保険 雇用保険

休日休暇
土曜日 日曜日 祝日

給与
年収600 ~ 800万円

賞与
-
雇用期間
期間の定めなし

show more

Job Tags

Similar Jobs

TalentSphere Staffing Solutions

RRT - Registered Respiratory Therapist Job at TalentSphere Staffing Solutions

 ...Are you a dedicated Registered Respiratory Therapist passionate about providing the most positive outcome for your patients, tech savvy and committed to lifelong learning? Looking for a fresh new view? Love the feel of a crisp lab coat and the smell of new paint?Join... 

DSV - Global Transport and Logistics

Senior Business Analyst, EDI Job at DSV - Global Transport and Logistics

 ...our customers. Read more at Location: USA - Houston, 831 Division:GroupJob Posting Title: Senior Business Analyst, EDITime Type: Full Time Summary The Senior Business Analyst (BA), EDI is in charge of overall integration projects for... 

Global-e

Merchant Support Agent Job at Global-e

We are looking for an experienced and proactive Merchant Support Agent to join our team in Japan(US/IL/Aus). In this role, you will be responsible for delivering swift and efficient service to both merchants and end customers. Key Re... 

Randstad

industrial painter / powder coater / spray painter. Job at Randstad

Calling all candidates with POWDER COATING/INDUSTRIAL PAINTER/SPRAY PAINTER experience!! Are you looking for your next PERMANENT job opportunity...  ...your updated resume to ****@*****.*** and cite "Powder Coat Team Lead" If this job is not for you but youre interested...