Manager/Sr. Manager, Clinical GCP Quality Assurance

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 Manager/Senior Manager of Clinical GCP Quality will be responsible for evaluating and mitigating risk of the global clinical development programs, from initiation through completion of clinical trials, with inspection readiness in mind throughout. The ideal candidate will advise on company clinical quality strategy, ensure compliance to regulations, oversee quality management systems and interact directly with cross functional clinical, regulatory and quality teams. The ideal candidate will have at least 10 years of experience in clinical quality, process improvement, regulatory inspection management and at least two years of clinical auditing experience as lead auditor. The candidate will have an excellent working knowledge of Good Clinical Practices (ICH E6), quality requirements and other international regulations (e.g. US, EU, Taiwan, India, Japan) are desirable.

Key Duties and Responsibilities

• Provide strategic and operational leadership in the planning and executing of GCP Quality activities to support companywide and clinical development/clinical trial Quality activities.

• Successfully lead global and cross-functional quality projects

• Maintains current knowledge of ever-changing clinical quality guidance and regulations.

• Excellent communication and people skills to ensure cohesive and collaborative teamwork.

• Demonstrated ability to implement and collaboratively drive company initiatives and policies.

• Experience in clinical inspection readiness and acting as the point person for sponsor clinical inspections. Lead Quality hosting clinical site inspection by regulatory agencies highly preferred.

• Direct experience to successfully manage and oversee CAPA plans (write, review, approve, close).

• Successfully demonstrates ability to both conduct and manage sites, internal GCP and vendor audits as well as direct and guide audit follow-up actions.

• Establish Quality and Cross-Functional SOPs, processes and associated documents.

• Working closely with clinical pharmacovigilance team on supporting clinical trial safety.

• Responsible for presenting & updating CGP quality metrics and reporting to Sr. Management.

• Other duties as assigned.

Desired Education, Skills and Experience

• B.S. Degree in life sciences with advanced degree in a scientific discipline preferred.
• Minimum of 10 years direct experience in GCP Quality Assurance and/or GCP Compliance.
• Minimum of two years of GCP auditing (e.g. clinical site/clinical vendor) as lead auditor experience preferred.
• Demonstrates strong problem-solving skills, written and verbal communication, and experience in critical QA review of clinical documents.
• Previous experience with oncology, combination drug-device studies, and/or multi-regional with US based clinical trial experience is a plus.
• Pharmacovigilance/Safety QA experience is a plus.
• Medical Device GCP experience is a plus.
• ISO Standard (e.g. ISO13485, ISO9001, ISO27001) understanding is a plus.
• Medical Device Reporting (MDR) – FDA 21 CFR Part 803.
• Pharmacovigilance laws -EU Regulation 520/2012 for drug safety monitoring.
• Experiences with Clinical Quality Management on a risk-based approach is needed.
• Electronic TMF, document, quality, and learning management systems experience
• Strong organizational and project management skills.
• Flexible thinking and team-oriented communication and coordination skills to be able to collaborate in a team environment.
• Professional working proficiency in English

REQUIREMENTS:

Physical Demands

• None, other than those necessary to perform the essential job functions

Manual Dexterity

• None, other than those necessary to perform the essential job functions

Audible/Visual Demands

• Ability to interpret the letters and numbers when viewed on a personal computer screen, PDA, reports and other documents.

Environment

• None, other than those necessary to perform the essential job functions.

Travel

• Up to 30%

The expected salary range for this position based in California is $150,000 to $170,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors.