Manager, External Quality Assurance

This position is responsible for all aspects of GMP and related systems and processes supporting CMO Management. This person will act as a Quality Ambassador focusing and influencing Contract Manufacturing Organizations (CMO’s) to comply with Astellas quality standards, policies and industry cGMP requirements. This position will serve as the main point of contact between Astellas and external CMO’s for quality issues and has oversight of Supplier Evaluation Programs, Quality Agreements, Change Management, CMO Annual Product Reviews and Quality Risk Management. This position communicates potential risks to line manager for appropriate action in collaboration with colleagues and affiliates.

Responsible for, managing the following quality systems for Astellas CMO products: Deviation Management (including CAPA), Change Control, SQIM, Risk Evaluation Committee, Audits, Stability, Annual Product Review, Complaints, Supplier Evaluation, Quality Business Review Meetings and Regulatory Intelligence

【職務の内容 / Essential Job Responsibilities】

（雇入れ直後）

CMO QA Oversight:

・Oversees the GMP activities and processes for Astellas commercial drug substances, intermediates, and in-process and finished drug products manufactured for Astellas by CMOs, supported by line management.

・Provide QA support for regulatory agency inspections at CMOs as necessary.

・Participate in CMO Business Review Meetings.

Assessment of the effectiveness/compliance of the Quality System in CMOs

・Facilitates the resolution of all deviations, non-conformances and other batch related quality issues with the CMO to ensure product compliance.

・Employs a Risk Management approach to evaluate Quality issues to ensure that drug substances, intermediates, and in-process and finished drug products manufactured for Astellas by CMOs conform to all regulatory and Astellas product specifications.

・Participates in the CMO Evaluation Program for CMO products as required.Develops and distributes formal reports in a collaborative manner.Cooperates with Supply Chain, Purchasing, and Quality Systems groups to maintain a list of approved CMOs.

・Identifies and communicates major GMP compliance issues to line Management. Participates in formal corrective/preventive action plans using a Risk Based approach.

・If required may support in the audit and inspection of CMOs by Health Authorities, external consultant and Global Quality Systems. Support special audit of the plants and contract manufacturer, as required.

Compliance:

・Embed Compliance Culture across all Regions of the business ensuring Integrity in Action is actively applied in all initiatives.

・Ensure the Product QA Function strictly adopts a culture of ethics and compliance; leading by example and appropriately challenging non-compliance.

・Ensure adherence to Astellas policies relating to Ethics and Compliance standards and interactions with Healthcare Professionals (HCPs), Healthcare Organisations (HCOs) and Patient Organisations (POs).

Surveillance of Significant Quality Issues (SQIs) and resultant investigations in the Region.

・Assures CMO compliance with Astellas corporate policies, Global Procedures and Guidelines, SOPs and regulatory agency standards.

・Supports QA assessments of SQIs and REC activities, under the guidance of line manager.Maintains related records and tracking systems.

・Support the coordination of recalls, as well as notifications to regulatory agencies.

QA Activities

・Supports the Continuous Improvement programme. Develops and maintains effective relationships with internal and external stakeholders which may include regional Astellas entities.

・Participation in cross functional teams supporting commercial products.

・Authors, revises, and performs maintenance and administration of departmental controlled documents (i.e., SOPs, WPDs, Forms, etc.) as necessary

・Monitoring and periodical review of CMO Management Quality System and participation in Management Review activities.

・Participates in a for-cause audit of the plants and contract manufacturer, as required.

・Evaluate product quality reviews and address questions and comments raised by marketing authorisation holders.

・Other such duties as may be reasonably required by the business.

（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.

・Some travel is expected for this role, mostly in region

【応募要件 / Qualifications】

＜必須 / Required＞

・Science Graduate or equivalent professional qualification and/or proven expertise

・Pharma sector experience

・Proven compliance expertise; to understand and comply with industry laws and relevant regulations.

・Coaching and collaboration skills to interact with all levels of personnel to achieve shared goals.

・Proven ability to influence, (appropriately) challenge and engage diverse senior stakeholders.

・Fluent in written and verbal business English

＜歓迎 / Preferred＞

・Previous experience in pharmaceutical Quality Assurance, CMO oversight or in-plant GMP pharmaceutical manufacturing

【応募書類 / Application Documents】

和文履歴書（必須）・和文職務経歴書（必須）・英文レジュメ（任意）

Resumes

【選考プロセス / Selection details】

書類選考 → 1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 → 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またはスーパーフレックス制

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 or Flex-time 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."

【What awaits you at Astellas? 】

•Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.

•Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.

•Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.

•A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

【Our Organizational Values and Behaviors】

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.