Senior Manager, Quality Assurance, Japan

Position Summary:

ultrafocused Work together to fearlessly uncover new possibilities

The Senior Manager QualityAssuranceJapan supports the Head of QualityAssuranceJapan and leadsday to dayQA 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 GQPwhile considering relatedGDP guidelinesGCP andPVrequirementsand supports the establishment of the local QA support model and supply chain model providing technicalassistanceas needed.

Work Model:

Remote: Officially documented as working full-time from home with travel to Ultragenyxs offices or other locations on occasion as needed.

Responsibilities:

1. Under the direction of the Head of QualityAssuranceJapan lead daytoday execution of QA activities and contribute to ontime completion.
2. Support compliance with internal policies SOPs industry standards (GMP/GQP/GDP) andPMDA/MHLWnotifications andguidance; support inspection readiness dayof activities and drafting postinspection responses.
3. Perform batch disposition (product release)in accordance withJapanese GQP requirements and support communications with regulators on quality matters.
4. Oversee domestic product testing and visual inspection results and promptly report any manufacturing quality control or product quality issuesidentifiedduring batch disposition activities to theGeneral Marketing ComplianceOfficer the Head of QualityAssuranceJapan and relevant stakeholders.
5. Author revise and implement SOPs and quality documents; support operation and continuous improvement of the QMS in line with corporate standards.
6. Collaborate with CMC QA QC Technical Operations Regulatory Affairs and Supply Chain to ensure a safe uninterrupted and effective supply of products thatmeetspatient and regulatory expectations.
7. Execute and drive quality processes such as change management deviations/CAPA product quality complaint investigations and product recallactivitiesin collaboration with Global Quality.
8. Draft and manage QualityTechnicalAgreementsandensure their effective implementation including support forGxPaudits and supplier qualityoversightof contracted partners such as CMOs contract testing laboratories and distributors.
9. Provide QA support for artwork management and facilitateJapaneseEnglishcommunications between domestic partners and global technical team.
10. 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.

Requirements:

1. Bachelors degree (or equivalent qualification) in a scientific discipline such as Pharmacy Biology Chemistry or Biochemistry.
2. At least7years of experience in the pharmaceutical or medical device industryincludingat least 5 years in a quality organization within a regulated industry.
3. 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).
4. In-depth understanding of Japanese GMP and GQP regulations GDP guidelines and PMDA/MHLW laws ordinances and notifications.
5. Experience in negotiating and managing quality agreements as well as vendorrelationshipand performance management.
6. Excellent written and verbal communication skills in both Japanese and English with strong interpersonal skills to collaborate effectively within cross functional teams.
7. Proficiencyin the use of risk assessment and root cause analysis (RCA) tools.
8. Experience applying quality systems and requirements across preclinical clinical and commercial stages.
9. Strong planning organizational and time management skills with the ability to prioritize and execute multiple projects in a fast paced environment.
10. Ability to travel domestically and internationally including Ultragenyx officesin Japan and the United Statesand vendor sites asrequired.

#LI-CK1 #LI-Remote

Position Summary:

Senior Manager QualityAssuranceJapanはHead of QualityAssuranceJapan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CMCQualityQC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GMPGQPを中心とし関連するGDPガイドラインGCPPV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 QualityAssuranceJapan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

Responsibilities:

1. 日本国内の品質保証QA業務についてHead of QualityAssuranceJapan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
2. 社内ポリシーSOP業界標準GMPGQPGDPPMDAMHAL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
3. 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
4. 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 QualityAssuranceJapan及び関係責任者へ速やかに報告します
5. 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
6. CMC QAQC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
7. 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
8. 品質契約QualityAgreementsQualityTechnical 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
9. 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
10. 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

Requirements:

1. 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
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
3. 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
4. 日本のGMPGQP規制GDPガイドラインPMDAMHLWの法令通知への深い理解
5. 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
6. 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
7. 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
8. 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
9. 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
10. 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