General Information

Job Advert Title: Lead, Quality Assurance, Vendor Management

Location: Nihonbashi, Tokyo

Division: Quality Assurance

Employment Class: Permanent

Description

【募集の背景 / Purpose & Scope】
Responsible for management and oversight of the Quality Assurance (QA) vendor oversight program for vendors used by Astellas for GxP regulated activities, to ensure compliance with regulations in Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practice (GLP), and Electronic Records Electronic Signatures (ERES) and Electronic Systems/Computerized System Validation (CSV).
Defines and implements the QA vendor audit strategy and executes the QA Vendor Management strategy to ensure vendor quality oversight which includes assessing vendors using risk ranking methodologies and quality evaluations.
The role is responsible for developing, executing, and maintaining the Vendor Management strategy to achieve annual objectives.

【職務の内容 / Essential Job Responsibilities】
（雇入れ直後）
  1. Contributes to the design and strategic direction of QA Vendor Management oversight and support to the Astellas organization in collaboration with QA Leadership team and stakeholders globally.
  2. Responsible for the development, implementation and execution of the QA vendor audit strategy and procedures in close collaboration with all QA functions.
  3. Leads the creation of the vendor audit schedule based on assignment of tier to the service and risk rating of the vendor, in compliance with the pre-defined QA Vendor Management policies and procedures.
  4. Responsible for oversight of the execution of the vendor audits in collaboration with QA and appropriate Astellas business functions globally. Develops, maintains, and communicates vendor list including qualification status, which is the primary means of communicating the vendor status to the organization and regulatory Health Authorities for vendor selection and inspection purposes.
  5. Responsible for oversight of annual Audit Schedule completion for vendor audits, for evaluating new vendors or vendor services being used by the business during the fiscal year.
  6. Responsible for vendor oversight and risk mitigation, through participation in vendor governance activities including evaluation of quality metrics (Key Quality Indicators) and issue escalation along with appropriate Astellas business stakeholders for defined preferred providers in collaboration with the Director, QA VM.
  7. Leads Quality to Quality meetings with key vendors to ensure evaluation and resolution of escalated Quality issues.
  8. Leads Quality Issue escalation within Astellas and Vendors. Communicates and engages Astellas and Vendor Senior Leadership to drive resolution of these complex issues.
  9. Responsible for risk rating of vendors and tier assignment of services to determine the type of assessment required and communicates impact to stakeholders across QA Functions, Procurement and appropriate Astellas business functions.
  10. Serves in a leadership role in managing contract auditing companies (CAC) contracted by QA to conduct audits and trainings on their behalf, or to provide quality consultancy services. In collaboration with QA-LT members, communicates the outsourcing forecasts to the CAC and manages the contracts with the CAC. Seeks opportunities for cost-effectiveness. Drives contract negotiations in collaboration with Procurement.
  11.  Maintains a state of Inspection Readiness: ensures that vendor auditing complies with defined audit strategies, is supported by quality documentation, and supports the Quality Systems group in ensuring that external staff training status is up to date, documented and readily available.
  12.  Responsible for supporting the conduct of high profile/niche vendor audits including for-cause vendor audits.
  13.  Represents QA in GxP regulated Astellas vendor sourcing initiatives globally. Provides quality requirements and evaluates potential vendors against these quality requirements. Engages QA Functions, as appropriate, to provide input on sourcing strategy objectives and communicates executed sourcing strategy outcomes across QA Functions.
  14.  Represents QA in vendor governance and oversight activities.
  15.  Responsible for forging strong collaborative relationships with internal QA key stakeholders and functions, and with relevant external stakeholders within the Astellas organization.
  16. Actively maintains knowledge on current developments in vendor management within the pharmaceutical industry and trains QA staff in vendor auditing.
  17.  Domestic and international travel at 5-10% is required.

（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】
• At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

【応募要件 / Qualifications】
＜必須 / Required＞
• Minimum Bachelor of Science degree.
• Minimum of 7 years of experience in the pharmaceutical, biotechnology, or related industry.
• Proven experience, with GxP (GCP, GVP, GLP, ERES, CSV, and/or GMP), Quality Management Systems and quality support including quality oversight of vendors providing GxP regulated services.
• Proven experience driving for results and implementation of deliverables.
• Ability to multi-task across several initiatives, projects and deliverables.
• In-depth understanding of GxP requirements for both investigational and marketed products.

＜歓迎 / Preferred＞
• Significant experience in auditing and vendor relations.
• Strong hands-on experience and understanding of Vendor Management as applied throughout the entire pharmaceutical compound/product life cycle.
• Proficiency in Microsoft Office.

【応募書類 / Application Documents】
和文履歴書・和文職務経歴書・英文レジュメ
Both Japanese and English Resumes are needed

【選考プロセス / Selection details】
書類選考 → 1次面接 → 2次面接 → 最終面接
※変更の可能性もございますので、予めご了承下さい。
CV screening → First interview → 2nd Interview → Final interview
*Please be advised that there might be a change in the process.

【勤務地 / Location】
（雇入れ直後）
東京都中央区　アステラス製薬　日本橋事業所　本社
Nihonbashi, Tokyo

（変更の範囲）
会社の定める事業場および自宅

【勤務開始日 / Start Date】
応相談
Will be decided according to the candidate's flexibility

【契約期間 / Contract Duration】
期間の定めなし
Not limited to specified period

【試用期間 / Probation Period】
試用期間原則なし
No probation period in principle

【給与 / Salary】
①基本給：当人の経歴・技術・技能等を考慮して決定
②裁量労働制の場合：裁量労働手当として職務グレードに応じて50,000～100,000円支給
③フレックスタイム制の場合：月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給
①Base salary: will be decided by the candidate's experience, skill and capability.
②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000～100,000yen, based on the Grade)
③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.

【昇給 / Salary Raise】
有り

【賞与 / Bonus】
有り

【諸手当 / Allowance】
裁量労働手当、住宅手当、通勤手当　等
Discretionary work allowance, Housing allowance, Commutation allowance, etc.

【勤務時間 / Working Hours】
8:45～17:45（月～木）、8:45～16:00（金）、企画業務型 裁量労働制
裁量労働制の場合、所定労働時間を働いたものとみなす
8:45～17:45（Mon～Thu）、8:45～16:00（Fri）
Discretionary Work System

【休日 / Holidays】
完全週休２日制（土曜・日曜）、祝日、5月1日、夏季、年末年始
Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays

【休暇 / Vacation Leave】
年次有給休暇、育児休業制度、介護休業制度　等
Annual paid leave, childcare leave system, nursing care leave system, etc.

【福利厚生 / Welfare】
雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度　等
Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System

【アステラス製薬　採用サイト/ Career web site】
https://re-jp.astellas.com/jp/recruit/newgraduates/
For more information about Astellas, please visit our career web site.
"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."

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