Quality Control Lead

Make your mark for patients

患者さんのためにあなたの力を発揮してください

私たちはQuality Control Lead を募集しています
責任感があり協調性が高く柔軟な対応ができる方を埼玉サイト運営チームにお迎えしたいと考えています
勤務地は埼玉勤務のポジションです

チームについて
製品の品質を保証する品質管理部門を率いるチームの一員として働くことになります
品質管理部門は原材料から最終製品までの品質を確保するため製造品質保証規制対応など他部門と連携しながら業務を遂行しています
Quality Control Leadは埼玉サイトのリーダーシップチームの一員としてサイト全体の運営にも関与します

主な業務内容
品質管理チームの採用育成評価を含むマネジメント
試験室の運営と設備の管理
分析方法の検証と新規方法の開発
原料中間体製品の品質試験と判定
逸脱や異常の調査と是正予防措置の実施
記録の維持と規制対応のための文書管理
品質管理プロセスの継続的改善と指標の導入
他部門との連携および監査対応

応募資格
理系学部学士以上
製薬業界10年以上のご経験
品質管理または関連分野QARDなどでのご経験5年以上
人材マネジメント経験3年以上
ビジネスレベルの英語力ネイティブレベルの日本語力

求める経験スキル
品質管理または分析化学の分野での実務経験
チームマネジメントの経験とリーダーシップスキル
分析方法の検証開発に関する知識
製造現場での品質管理業務の理解
GMPや日本薬局方などの規制知識
他部門との協働経験と高いコミュニケーション能力
プロジェクトマネジメントの経験

応募方法
日本語と英語の履歴書を1つのファイルにまとめシステム上でアップロードしてください
UCB社員からの紹介がある場合は応募時にその旨をシステム上でご記入ください

(English follow)

Job Summary
Quality Control (QC) Lead reports to Head of Saitama Site and oversees the QC department to ensure product quality from incoming materials to outgoing products based on GMP and Japan Pharmacopeia (JP). The position is part of Site Leadership Team (SLT) and oversee entire activities of Saitama Site.
Major Accountabilities/Responsibilities

1. Team Management:
Lead and manage the QC team including hiring training and performance evaluation of personnel.
Ensure that the QC team is adequately trained and equipped to perform their duties effectively.
2. Laboratory Management:
Oversee the operation of the QC laboratory ensuring that equipment is properly calibrated and maintained.
Coordinate the testing of raw materials in-process samples and finished products to ensure they meet quality specifications.
3. Method Validation and Development:
Oversee the validation of analytical methods used in the QC laboratory to ensure their accuracy precision and reliability.
Work on the development and optimization of new analytical methods as needed.
4. Quality Control Testing:
Ensure that all products undergo rigorous testing for identity purity potency and other quality attributes.
Review and approve or reject raw materials intermediate products and finished goods based on established specifications.
5. Investigations and Troubleshooting:
Lead investigations into deviations out-of-specification results and other quality incidents.
Implement corrective and preventive actions to address identified issues and prevent their recurrence.
6. Documentation and Record Keeping:
Oversee the maintenance of accurate and complete records for all QC activities.
Ensure that documentation meets regulatory requirements and is readily available for inspections.
7. Continuous Improvement:
Identify opportunities for continuous improvement in QC processes and systems.
Implement and monitor key performance indicators (KPIs) to assess the effectiveness of the QC function.
8. Communication and Collaboration:
Collaborate with other departments such as Production Quality Assurance and Regulatory Affairs to ensure effective communication and coordination.
Represent the QC department during regulatory inspections and audits.

1. Operational Oversight:
Provide strategic direction and leadership to achieve operational objectives.
Oversee daily factory operations to ensure efficiency and productivity.
Collaborate with other leaders to optimize workflows and resource allocation.
2. Team Leadership and Development:
Build and lead a high-performing team fostering a positive and collaborative work environment.
Set clear expectations and goals for the team members.
Provide coaching mentorship and development opportunities to enhance team capabilities.
3. Strategic Planning and Decision-Making:
Contribute to the development and implementation of strategic plans for the factory.
Make informed and timely decisions to address challenges and opportunities.
Collaborate with other members of the leadership team to align factory goals with overall organizational objectives.

Education & Qualifications
Education Level Bachelors Degree
Experience : At least 10 years in Pharma Industry 3years in people management position and 5years in QC Area or equivalent (e.g. QA R&D)

Competencies
Technical Skills
1. Quality Related Expertise:
In-depth knowledge of pharmaceutical manufacturing processes quality control testing methods and analytical techniques.
Familiarity with relevant regulations and guidelines including Good Manufacturing Practices (GMP) Good Laboratory Practices (GLP) and pharmacopeial standards.
2. Analytical Skills:
Strong analytical and problem-solving skills to assess and address deviations out-of-specification results and other quality issues.
Ability to interpret complex data and make informed decisions based on analytical results.
3. Regulatory Compliance:
Thorough understanding of regulatory requirements and the ability to ensure that the QC activities align with these regulations.
Stay updated on changes in regulatory standards and implement necessary updates to maintain compliance.
4. Documentation and Record Keeping:
Attention to detail and strong documentation skills to maintain accurate and complete records of QC activities.
Ensure that documentation meets regulatory standards and is readily available for inspections.
5. Problem Solving and Decision-Making:
Ability to make sound decisions in high-pressure situations especially when dealing with deviations or quality issues.
Proactive problem-solving skills to identify and address potential quality concerns before they escalate.
6. Project Management:
Effective project management skills to oversee multiple testing projects simultaneously.
Prioritize tasks and allocate resources appropriately to meet project timelines and quality objectives.
Leadership Competencies:
1. Communication Skills:
Effective communication with team members other departments and upper management include Global organization.
Ability to convey complex concepts in a clear and understandable manner.
2. Strategic Thinking:
Align team objectives with the overall strategic goals of the organization.
Contribute to the development and execution of corporate and site strategies.
3. Decision-Making and Problem-Solving:
Make informed decisions based on her/his professional knowledge and data analysis.
Address complex issues through systematic problem-solving approaches.
4. Team Leadership:
Build and lead a high-performing team.
Foster a culture of collaboration accountability and continuous improvement.
5. Ethical Leadership:
Uphold high ethical standards and promote a culture of integrity.
Ensure compliance with ethical principles in all activities.
6. Adaptability and Change Management:
Navigate and lead the team through changes in business conditions or organizational structures.
Demonstrate adaptability and resilience in the face of challenges.
7. Influence and Stakeholder Management:
Effectively influence and collaborate with cross-functional teams.
Manage relationships with Global initiatives relevant authorities and other stakeholders.
8. Training and Development:
Develop and implement training programs for site employees.
Promote a culture of continuous learning and skill development.
9. Conflict Resolution:
Address conflicts within the team and with other departments.
Facilitate resolution and maintain a positive work environment.
10. Strategic Alignment:
Align all site initiatives with broader business strategies of Local and Global.
Contribute to the development of organizational policies.

Required.

患者さんのために価値を創造しあなたの力を発揮してその先に進む準備はできていますかもしそう思われるならぜひご応募ください

UCBについて
UCBは神経学と免疫学に特化したグローバルなバイオ医薬品企業ですUCBは世界各地に約8500人の従業員を擁し患者さんに触発され科学を原動力としています

UCBで働く理由
UCBでは単に仕事をこなすだけでなく価値を創造します私たちは患者さんのために前進し協力し革新することを恐れませんUCBには思いやりがあり協力的な社風がありますそこでは誰もが仲間とともに尊重されベストを尽くす機会を公平に与えられています私たちは患者さん従業員地球のいずれに対しても常に人間的な視点に立ち患者さんのために価値を創造するその先を目指しますUCBで働けば自分が成長できる場所を発見し自分の可能性を最大限に発揮するために自分のキャリアパスを切り開く自由を得ることができます

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