Senior Manager, Quality Assurance, Japan

Position Summary:

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. 

Work Model:

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

Responsibilities:

1. Under the direction of the Head of Quality Assurance Japan, lead day‑to‑day execution of QA activities and contribute to on‑time completion.  
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. 
3. Perform batch disposition (product release) in accordance with Japanese 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 issues identified during batch disposition activities to the General Marketing Compliance Officer, the Head of Quality Assurance Japan, 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 that meets patient and regulatory expectations. 
7. Execute and drive quality processes such as change management, deviations/CAPA, product quality complaint investigations, and product recall activities in collaboration with Global Quality. 
8. 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.  
9. Provide QA support for artwork management and facilitate Japanese–English communications 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. Bachelor’s degree (or equivalent qualification) in a scientific discipline such as Pharmacy, Biology, Chemistry, or Biochemistry. 
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. 
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 vendor relationship and 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. Proficiency in 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 offices in Japan and the United States and vendor sites, as required. 

#LI-CK1 #LI-Remote

Position Summary:

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。 

Responsibilities:

1. 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。 
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。 
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 Quality Assurance Japan、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 goawsgcpaidataproductmarketing