Global Head of Quality Assurance (VP/SVP)

Company Profile

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.

Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.

Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.

Company Profile

Rakuten Medical, Inc. is a global biotechnology company developing precision, cell-targeting investigational therapies on its Alluminox technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.

Our first clinical product received marketing approval in Japan from the Ministry of Health, Labour and Welfare for ASP-1929 PIT to treat unresectable locally advanced or recurrent head and neck cancer - and is also in Phase III pivotal clinical testing globally to treat terminal cancer patients. This is a first-in-class product with unique pharmacological activity and with the potential to have a broad impact in cancer.

Rakuten Medical is committed to its mission to conquer cancer and aims to realize a society where cancer patients can lead fulfilling lives. Headquartered in the United States, Rakuten Medical has 5 locations in 5 countries: the United States, Japan, Taiwan, Switzerland and India. For more information, visit www.rakuten-med.com.

Position Summary

The Head of Quality Assurance (QA) will be a key member of the Rakuten Medical team with Global responsibility for establishing and administering all Quality functions related to our drug, device and clinical operations . The Head of QA will provide quality oversight and support Rakuten Medical's product manufacturing, product distribution, pre-clinical, clinical oversight, and operations. The Head of QA will be responsible for ensuring compliance with established company quality policies, practices, standard operating procedures (SOPs) and federal/country regulations. The position may require domestic and international travel primarily to Rakuten Medical sites, CRO, CMO, Suppliers locations to conduct audits, and vendor oversight to ensure compliance and quality. The chosen candidate will lead global quality and report to the President of Rakuten Medical. The candidate will have strong leadership, communication, collaboration skills with the ability to prioritize, set goals and meet objectives applying a risk-based compliant approach while working with cross-functional teams. The Head of QA will be responsible for the company's compliance of development and commercial stage combination products including oversight of the Quality Management System (QMS). The candidate will also be responsible for inspection readiness and preparedness, documentation systems, and contract service provider qualification and management.

This position plays a critical role in ensuring compliance with regulatory standards and enhancing the quality management system across the organization. The incumbent will lead efforts in quality governance, and represent the company in interactions with health authorities, while fostering a culture of continuous improvement and innovation within the R&D, clinical, and commercial teams.

Key Duties and Responsibilities

• Responsible for the establishment and administer Rakuten Medical's Quality Management System (QMS)
• Responsible for all quality functions related to clinical, commercial, product manufacture which includes the combination of drug and device
• Ensure the company compliance with relevant global quality and regulatory requirements
• Contributes to the development of clinical trial protocols
• Responsible for the Rakuten Medical electronic document management systems (EDMS)
• Interprets relevant guidelines/processes information and takes appropriate actions to inform and educate stakeholders and revise processes as necessary
• Oversee the global vendor selection, assessment, and qualification
• Oversee the quality audits, inspections and budget of the Rakuten Medical vendors
• Provide device quality oversight of design and development activities, ensuring compliance with design control requirements (21 CFR 820.30, ISO 13485)
• Participate in device design reviews, risk management activities (ISO 14971), and verification/validation processes
• Monitor and maintain compliance with ICH-GCP, FDA, EMA, PMDA, and other applicable regulatory guidelines
• Support implementation of risk-based quality management for clinical trials per current ICH guidelines
• Oversees the investigation of quality-related issues, development and implementation of corrective and preventative action plans (CAPA), tracking their effectiveness and presenting metrics to leadership
• Responsible for generating a preapproval compliance strategy for Rakuten Medical commercial products
• Support and provide guidance on late stage process validation activities
• Ensure annual licenses, registrations, listings, and patent information are maintained
• Ensure compliance with product post-marketing approval requirements
• Support advertising and promotional items are compliant to regulatory requirements
• Review and approve publicly disseminated information
• Review product claims and preserves confidentiality of applicable product information
• Oversee quality aspects of business relationships to ensure compliance and protect corporate interests
• Represents the organization during regulatory agency inspections
• Recruit, develop, and manage the Quality Assurance functional areas as the company's pipeline and development activities grow
  
  

Desired Education, Skills and Experience

• Extensive biopharma experience in clinical research and quality assurance, with a strong understanding of GCP, cGMP, GLP, GVP, GDP, device QMS, and other relevant regulations and standards
• Experience with both drug and device supporting oncology trials
• Functional head of a quality department
• Experience of Management Representative per ISO 13485 preferred
• 10+ years of Quality Assurance industry experience
• Experience monitoring costs of projects, as well as human and material resources within a department or unit
• Experience in preparing, hosting and managing regulatory inspections (includes FDA, EMA, MHRA, PMDA) for both manufacturing and clinical.
• Strong critical thinking, problem-solving, and decision-making skills, as well as dealing with ambiguity
• Strong organizational and time-management skills to manage multiple projects and priorities effectively
• Excellent oral and written communication skills
• Business travel is typically up to 15-20% of time, but it may be higher on occasion based on business needs
• Ability to work independently, analyse, work with attention to detail, and process and prioritize sensitive complex information
• Excellent interpersonal, team building, and motivational skills
  
  

We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more.

Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.

The expected salary range for this position based in California is $200,000 to $230,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.

We are proud to offer a competitive compensation plan with an excellent benefits package including flexible time off, stock options, 401k, medical, dental, vision plans and more for full time employees. We recommend anyone coming onsite to be vaccinated for COVID-19. Rakuten Medical Inc. is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to building a team that represents a variety of backgrounds, perspectives and skills.