Senior Manager, Quality Assurance, Japan at Ultragenyx Pharmaceutical

Tokyo, JapanFull-timeQualityPosted 30 days ago

About the Role

<div class="content-intro"><div>Why Join Us?</div> <div> </div> <div>Be a hero for our rare disease patients</div> <div> </div> <div>At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. </div> <div> </div> <div>Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.</div> <div> </div> <div>If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team. </div></div><h3 style="text-align: left;">Position Summary:</h3> ultrafocused – Work together to fearlessly uncover new possibilities The Senior Manager, Quality Assurance Japan, supports the Head of Quality Assurance Japan and leads day to day QA operations to sustain product launch and commercial activities. Partnering with CMC Quality, QC, Technical Operations, and Supply Chain, the role ensures operations aligned with Japanese GMP and GQP—while considering related GDP guidelines, GCP, and PV requirements—and supports the establishment of the local QA support model and supply chain model, providing technical assistance as needed.  <h3 style="text-align: left;">Work Model: </h3> Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed. <h3 style="text-align: left;">Responsibilities:</h3> <ol> <li style="line-height: 2;">Under the direction of the Head of Quality Assurance Japan, lead day‑to‑day execution of QA activities and contribute to on‑time completion.  </li> <li style="line-height: 2;">Support compliance with internal policies, SOPs, industry standards (GMP/GQP/GDP), and PMDA/MHLW notifications and guidance; support inspection readiness, day‑of activities, and drafting post‑inspection responses. </li> <li style="line-height: 2;">Perform batch disposition (product release) in accordance with Japanese GQP requirements and support communications with regulators on quality matters. </li> <li style="line-height: 2;">Oversee domestic product testing and visual inspection results, and promptly report any manufacturing, quality control, or product quality issues identified during batch disposition activities to the General Marketing Compliance Officer, the Head of Quality Assurance Japan, and relevant stakeholders. </li> <li style="line-height: 2;">Author, revise, and implement SOPs and quality documents; support operation and continuous improvement of the QMS in line with corporate standards. </li> <li style="line-height: 2;">Collaborate with CMC QA, QC, Technical Operations, Regulatory Affairs, and Supply Chain to ensure a safe, uninterrupted, and effective supply of products that meets patient and regulatory expectations. </li> <li style="line-height: 2;">Execute and drive quality processes such as change management, deviations/CAPA, product quality complaint investigations, and product recall activities in collaboration with Global Quality. </li> <li style="line-height: 2;">Draft and manage Quality Technical Agreements and, ensure their effective implementation, including support for GxP audits and supplier quality oversight of contracted partners such as CMOs, contract testing laboratories, and distributors.  </li> <li style="line-height: 2;">Provide QA support for artwork management and facilitate Japanese–English communications between domestic partners and global technical team. </li> <li style="line-height: 2;">Participate in external collaborations to stay current with domestic policies, practices, and regulatory guidance, and work with CMC Leads and Portfolio Management to support effective project planning and execution. Perform other duties as assigned, as needed. </li> </ol> <h3 style="text-align: left;">Requirements:</h3> <ol> <li style="line-height: 2;">Bachelor’s degree (or equivalent qualification) in a scientific discipline such as Pharmacy, Biology, Chemistry, or Biochemistry. </li> <li style="line-height: 2;">At least 7 years of experience in the pharmaceutical or medical device industry, including at least 5 years in a quality organization within a regulated industry. </li> <li style="line-height: 2;">Experience in product lifecycle management, with an understanding of development through commercialization for small molecules, biologics, and advanced therapies (e.g., gene therapy and mRNA). </li> <li style="line-height: 2;">In-depth understanding of Japanese GMP and GQP regulations, GDP guidelines, and PMDA/MHLW laws, ordinances, and notifications. </li> <li style="line-height: 2;">Experience in negotiating and managing quality agreements, as well as vendor relationship and performance management. </li> <li style="line-height: 2;">Excellent written and verbal communication skills in both Japanese and English, with strong interpersonal skills to collaborate effectively within cross functional teams. </li> <li style="line-height: 2;">Proficiency in the use of risk assessment and root cause analysis (RCA) tools. </li> <li style="line-height: 2;">Experience applying quality systems and requirements across preclinical, clinical, and commercial stages. </li> <li style="line-height: 2;">Strong planning, organizational, and time management skills, with the ability to prioritize and execute multiple projects in a fast paced environment. </li> <li style="line-height: 2;">Ability to travel domestically and internationally, including Ultragenyx offices in Japan and the United States and vendor sites, as required. </li> </ol> #LI-CK1 #LI-Remote   <h3 style="text-align: left;">Position Summary:</h3>   Senior Manager, Quality Assurance Japan は、Head of Quality Assurance Japan と共に日本における品質保証（QA）オペレーションを実務面から支え、製品上市・商業活動を支えるために必要なライセンス維持をサポートします。CMC Quality、QC、テクニカルオペレーション、サプライチェーンと連携し、グローバル（および国内）の GMP・GQPを中心とし、関連するGDPガイドライン、GCP、PVなどの要件との整合を考慮した運営を確保します。また、経営陣および Head of Quality Assurance Japan と協働して、国内の QA サポートモデルとサプライチェーンモデルを整え、必要に応じて技術的支援を提供します。    <h3 style="text-align: left;">Responsibilities:</h3>   <ol> <li style="line-height: 2;">日本国内の品質保証（QA）業務について、Head of Quality Assurance Japanの指示のもと実務遂行を主導し、期限内の完遂に貢献します。 </li> <li style="line-height: 2;">社内ポリシー・SOP、業界標準（GMP／GQP／GDP）、PMDA／MHALの法令通知やガイダンス への準拠を監督し、査察対応（事前準備、当日対応、照会事項・指摘事項への回答作成を含む）を担当し、当局とのコミュニケーションを支援します。 </li> <li style="line-height: 2;">日本のGQP要件に基づき、ロット判定（Batch Disposition） を実施し、品質関連事項について規制当局とのコミュニケーションを支援します。 </li> <li style="line-height: 2;">国内における製品試験結果・目視検査等を監督し、出荷判定関連業務で把握した製造・品質管理・製品品質に関する不具合 を総括製造販売責任者、Head of Quality Assurance Japan、及び関係責任者へ速やかに報告します。 </li> <li style="line-height: 2;">Ultragenyx Japan の SOP・品質文書 を作成・改訂・運用し、コーポレート基準／品質システム に準拠した運用と継続的改善を推進します。 </li> <li style="line-height: 2;">CMC QA／QC／テクニカルオペレーション／薬事／サプライチェーン と連携し、患者および当局の期待に応える 安全で途切れのない有効な製品供給 を確保します。 </li> <li style="line-height: 2;">グローバル Quality と連携し、変更管理、逸脱／CAPA、品質苦情調査、製品回収 などの品質プロセスを支援・推進します。 </li> <li style="line-height: 2;">品質契約（Quality Agreements／Quality Technical Agreements） を策定・管理し、委託先（CMO、外部試験機関、物流業者等）への GxP 監査支援／サプライヤー品質 を含め、効果的な実行を確保します。 </li> <li style="line-height: 2;">アートワーク管理 について、品質観点からを必要に応じて支援し、国内委託組織とグローバル技術チームの日本語コミュニケーション を円滑にするサポートを提供します。 </li> <li style="line-height: 2;">外部コラボレーション へ参加し国内政策・実務・最新ガイダンスを把握するとともに、CMC リード／ポートフォリオマネジメント と協働してプロジェクトの計画・実行・成果達成を推進します。必要に応じて その他の業務 を遂行します。 </li> </ol>   <h3 style="text-align: left;">Requirements:</h3>   <ol> <li style="line-height: 2;">科学系分野の学士号（薬学・生物学・化学・生化学など）または同等の資格。 </li> <li style="line-height: 2;">製薬／医療機器業界での実務経験 7年以上で、かつ規制産業の品質組織での経験 5年以上。 </li> <li style="line-height: 2;">製品ライフサイクルマネジメントの経験（低分子・バイオ医薬・先端治療〔遺伝子治療、mRNA〕の開発～商業化への理解）。 </li> <li style="line-height: 2;">日本のGMP／GQP規制、GDP ガイドライン、PMDA／MHLWの法令・通知への深い理解。 </li> <li style="line-height: 2;">品質契約の交渉・管理、およびベンダー関係・パフォーマンス管理の経験。 </li> <li style="line-height: 2;">日本語・英語の優れた口頭／文書コミュニケーション能力と、チームで円滑に協働できる対人スキル。 </li> <li style="line-height: 2;">リスクアセスメントおよび根本原因分析（RCA）ツールの活用に習熟していること。 </li> <li style="line-height: 2;">前臨床・臨床・商業の各段階に応じた品質システム／要件の適用経験。 </li> <li style="line-height: 2;">変化の速い環境で、複数プロジェクトの優先付けと遂行ができる計画力・組織力・タイムマネジメント能力。 </li> <li style="line-height: 2;">必要に応じて、 国内外のUltragenyxオフィス（日本／米国）やベンダー施設へ出張できること。 </li> </ol><div class="content-conclusion"><div> </div> <div>Full Time employees across the globe enjoy a range of benefits, including, but not limited to:</div> <div> </div> <div>·         Generous vacation time and public holidays observed by the company</div> <div>·         Volunteer days</div> <div>·         Long term incentive and Employee stock purchase plans or equivalent offerings</div> <div>·         Employee wellbeing benefits</div> <div>·         Fitness reimbursement</div> <div>·         Tuition sponsoring</div> <div>·         Professional development plans</div> <div> </div> <div>* Benefits vary by region and country</div> <div> Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at <a href="mailto:[email protected]">[email protected]</a>. </div> <div>See our <a class="postings-link" href="https://www.ultragenyx.com/CCPA-Notice/">CCPA Employee and Applicant Privacy Notice</a>.</div> <div>See our <a class="postings-link" href="https://www.ultragenyx.com/privacy-policy/">Privacy Policy</a>.</div> <div> It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. </div> <div>Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation.  Inquiries on developing a recruiting relationship with us, may be directed to: <a class="postings-link" href="http://mailto:[email protected]/">[email protected]</a>.</div></div>

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