Senior Manager, Quality Assurance

This is a fully remote position, open to applicants in Japan.

📋 Description

• Under the guidance of the Head of Quality Assurance Japan, manage and oversee daily QA operations to ensure timely completion.

• Assist in adhering to internal policies, standard operating procedures (SOPs), industry standards (GMP/GQP/GDP), and PMDA/MHLW notifications and guidance; facilitate inspection readiness, activities on the day of inspection, and draft responses after inspections.

• Carry out batch disposition (product release) in compliance with Japanese GQP requirements and aid in communication with regulators regarding quality issues.

• Supervise domestic product testing and visual inspection outcomes, and quickly report any manufacturing, quality control, or product quality concerns identified during batch disposition to the General Marketing Compliance Officer, the Head of Quality Assurance Japan, and other relevant parties.

• Create, update, and implement SOPs and quality documentation; assist in the operation and ongoing enhancement of the Quality Management System (QMS) in accordance with corporate benchmarks.

• Collaborate with CMC QA, QC, Technical Operations, Regulatory Affairs, and Supply Chain to ensure a safe, consistent, and efficient supply of products that align with patient and regulatory expectations.

• Implement and lead quality processes such as change management, deviations/CAPA, product quality complaint investigations, and product recall initiatives in partnership with Global Quality.

• Draft and oversee Quality Technical Agreements, ensuring their effective execution, including support for GxP audits and supplier quality oversight of contracted partners like CMOs, contract testing labs, and distributors.

• Offer QA support for artwork management and facilitate communication in both Japanese and English between local partners and the global technical team.

• Engage in external collaborations to remain informed about domestic policies, practices, and regulatory guidance, and work with CMC Leads and Portfolio Management to support effective project planning and execution. Perform additional duties as assigned, as necessary.

⛳️ Requirements

• A Bachelor’s degree (or equivalent qualification) in a scientific field such as Pharmacy, Biology, Chemistry, or Biochemistry.

• A minimum of 7 years of experience in the pharmaceutical or medical device sector, including at least 5 years within a quality organization in a regulated environment.

• Familiarity with product lifecycle management and an understanding of development through commercialization for small molecules, biologics, and advanced therapies (e.g., gene therapy and mRNA).

• Comprehensive knowledge of Japanese GMP and GQP regulations, GDP guidelines, and PMDA/MHLW laws, ordinances, and notifications.

• Experience in negotiating and managing quality agreements, along with vendor relationship and performance management.

• Exceptional written and verbal communication skills in both Japanese and English, complemented by strong interpersonal abilities to collaborate effectively within cross-functional teams.

• Proficient in utilizing risk assessment and root cause analysis (RCA) tools.

• Experience in applying quality systems and requirements across preclinical, clinical, and commercial phases.

• Strong planning, organizational, and time management skills, with the capacity to prioritize and manage multiple projects in a fast-paced setting.

• Willingness to travel domestically and internationally, including visits to Ultragenyx offices in Japan and the United States and vendor locations, as needed.

🏝️ Benefits

• Generous vacation time and public holidays recognized by the company.

• Volunteer days.

• Long-term incentive and employee stock purchase plans or equivalent offerings.

• Employee wellbeing benefits.

• Fitness reimbursement.

• Tuition sponsorship.

• Professional development plans.