Senior Manager, Quality Assurance
Ultragenyx
full-time
Posted on:
Location Type: Remote
Location: Japan
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Job Level
About the role
- Under the direction of the Head of Quality Assurance Japan, lead day-to-day execution of QA activities and contribute to on-time completion.
- 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.
- Perform batch disposition (product release) in accordance with Japanese GQP requirements and support communications with regulators on quality matters.
- 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.
- Author, revise, and implement SOPs and quality documents; support operation and continuous improvement of the QMS in line with corporate standards.
- 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.
- Execute and drive quality processes such as change management, deviations/CAPA, product quality complaint investigations, and product recall activities in collaboration with Global Quality.
- 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.
- Provide QA support for artwork management and facilitate Japanese–English communications between domestic partners and global technical team.
- 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
- Bachelor’s degree (or equivalent qualification) in a scientific discipline such as Pharmacy, Biology, Chemistry, or Biochemistry.
- 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.
- 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).
- In-depth understanding of Japanese GMP and GQP regulations, GDP guidelines, and PMDA/MHLW laws, ordinances, and notifications.
- Experience in negotiating and managing quality agreements, as well as vendor relationship and performance management.
- Excellent written and verbal communication skills in both Japanese and English, with strong interpersonal skills to collaborate effectively within cross functional teams.
- Proficiency in the use of risk assessment and root cause analysis (RCA) tools.
- Experience applying quality systems and requirements across preclinical, clinical, and commercial stages.
- Strong planning, organizational, and time management skills, with the ability to prioritize and execute multiple projects in a fast paced environment.
- Ability to travel domestically and internationally, including Ultragenyx offices in Japan and the United States and vendor sites, as required.
Benefits
- Generous vacation time and public holidays observed by the company
- Volunteer days
- Long term incentive and Employee stock purchase plans or equivalent offerings
- Employee wellbeing benefits
- Fitness reimbursement
- Tuition sponsoring
- Professional development plans
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
batch dispositionproduct releaseSOP authoringquality document implementationchange managementdeviations/CAPAproduct quality complaint investigationsproduct recall activitiesrisk assessmentroot cause analysis
Soft Skills
written communicationverbal communicationinterpersonal skillscollaborationplanningorganizational skillstime managementprioritizationexecutionnegotiation