Job Description

General Information

Job Advert Title:
Specialist, BioPharma QA

Location:
Nihonbashi, Tokyo

Division:
Quality Assurance

Employment Class:
Permanent

Description

【募集の背景 / Purpose & Scope】The primary purpose of the BioPharma QA Specialist is to facilitate the implementation of the global BioPharma Quality Assurance strategy in both local and global settings. The position will be located in Japan, preferably Toyama or Tokyo and will require global, cross functional work on a daily basis.
Areas of accountability include support of:・Global Biopharma QA QMS including CAPA, Deviation, Change Controls, Risk Assessment and Supplier Management・CTM manufacture and new product commercialization/launch of ATMPs/Biologics at Biopharma sites and/or CMOs・BioPharma QA initiatives, cross functional process harmonization & global/local project teams・Organizing, leading and using AI tools to translate and facilitate strategic Biopharma QA operations (Townhalls, Presentation Materials, Biopharma QA Organizational Structure etc.)

【職務の内容 / Essential Job Responsibilities】（雇入れ直後）●Collaborates with internal and external key stakeholders to contribute to development and alignment of processes, operating procedures, systems and/or programs that related to the compliance with the relevant regulations such as GMP/GDP in the program/projects for Astellas new commercial products and clinical trial materials with global regulatory requirements and to support business expansion of commercial products, according to the guidance and/or instruction by Group Leads and Team Leads in BioPharma Quality Assurance. ●Contributes to the BioPharma activities as a project team member and supports Biopharma QA Lead/Head or Site Head on assigned projects and oversees completion of quality related action items. ●Supports and consults any technical QA issues to relevant stakeholders, in order to comply with the relevant regulations.●Supports key activities in BioPharma QA Group as follows:・Supports the Biopharma QA QMS including CAPA, Deviation, Investigation, Change Control, Management Review, Risk Assessment and escalations as required. ・Supports planning, organization of local and global meetings in BioPharma Quality Assurance including preparation of translated materials. May act as secretariat.・Prepares specific technical QA guideline/SOP and/or policy documents under development and commercialization stages in support of BioPharma Plants and CMOs.・Supports vendor risk assessments and annual supplier audit planning and execution for BioPharma QA activities.・Supports due diligence activities for evaluation of business partners and new products as required・Manages new QA Agreements as necessary and periodic review・Supports engineering QA activities in Astellas manufacturing sites from GMP perspectives such as commissioning & qualification for the GMP facilities by Project BasisMaintains effective working relationships with internal and external stakeholder functions, including external partner quality organizations. Supports local site team members of BioPharma QA and foster an environment of collaboration, trust, quality, innovation, and continuous improvement within the departments and between Quality Assurance and other functional departments. ●If assigned to the Toyama site, actively participate in on-site GMP operations, supporting key QA tasks (but not limited to): deviation management, CAPA management, responding to domestic/international authority inspections, and collaboration with internal teams and partners.
（変更の範囲）会社内での全ての業務

【就業環境に関する要件 / Specific Physical or Environmental Requirements】・This position is based in Nihonbashi/Tokyo/Toyama and will require on-site work in accordance with site and management expectations. ・Candidates will be screened and interviewed to see if their ability, qualifications and aptitude matches the positions. Successful candidates can be promoted to the posting grade based on the Job Grade Change rules of API. However, there may be cases that candidates receive offer at the different grade from posting grade considering their ability, qualifications and aptitude.

【応募要件 / Qualifications】＜必é ˆ / Required＞・BA / BS (or equivalent) in a science or engineering related field, with minimum 2 years of BioPharma or pharmaceutical or consumer business industry experiences (in BioPharma, biologic, solid dose and/or parenteral manufacturing) related to QMS, CMC, GMP, GDP, GLP, GCP, Validation, QC and/or QA.・Conversational and business level English skills・High communication and interpersonal skills in a Global environment・Knowledge of GMPs/QMS and other relevant regulations, as required, with knowledge of quality principles and industry trends.・Experience with systems used in QMS (Veeva/Trackwise/LMS)・Effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to effectively work globally across Biopharma QA sites, other Astellas groups and with external stakeholders.
＜歓迎 / Preferred＞・Experience working in a Global environment・Experience in inspections by authorities and quality audits of business partners・Applied knowledge of global industry standards and regulatory requirements (e.g., US, EU and Japan).・Direct experience in Manufacturing or QMS Operations for BioPharma Industry.・Direct experience in Manufacturing Validation support (e.g., Cleaning, Process, Equipment, Requalification, Computer).・GMP/QMS auditing experience of Biologics, Solid Dose or Parenteral Manufacturing