Rakuten Medical Inc. - US
Sr. Manager/Associate Director, Clinical GCP Quality Assurance
Rakuten Medical Inc. - US, San Diego, California, United States, 92189
Position Summary
Reporting to the Chief Technology Officer, the Senior Manager/Associate Director of Clinical GCP Quality will be responsible for evaluating and mitigating risk of 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.
Maintain current knowledge of ever-changing clinical quality guidance and regulations.
Exhibit excellent communication and people skills to ensure cohesive and collaborative teamwork.
Demonstrate the 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).
Conduct and manage site, 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.
Work closely with clinical pharmacovigilance team on supporting clinical trial safety.
Present and update CGP quality review metrics and reporting to Sr. Management.
Other duties as assigned.
Desired Education, Skills and Experience
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 and 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 clinical 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.
Computer System Validation, Software validation & qualification for 21 CFR Part 11 compliance is a plus.
Experiences with Clinical Quality Management on a risk-based approach is needed.
Electronic TMF, document, quality, and learning management systems experience is needed.
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 or above in English.
REQUIREMENTS:
Travel
Up to 30%.
The expected salary range for this position based in California is $175,000 to $220,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors. Company is posting role confidentially.
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Reporting to the Chief Technology Officer, the Senior Manager/Associate Director of Clinical GCP Quality will be responsible for evaluating and mitigating risk of 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.
Maintain current knowledge of ever-changing clinical quality guidance and regulations.
Exhibit excellent communication and people skills to ensure cohesive and collaborative teamwork.
Demonstrate the 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).
Conduct and manage site, 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.
Work closely with clinical pharmacovigilance team on supporting clinical trial safety.
Present and update CGP quality review metrics and reporting to Sr. Management.
Other duties as assigned.
Desired Education, Skills and Experience
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 and 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 clinical 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.
Computer System Validation, Software validation & qualification for 21 CFR Part 11 compliance is a plus.
Experiences with Clinical Quality Management on a risk-based approach is needed.
Electronic TMF, document, quality, and learning management systems experience is needed.
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 or above in English.
REQUIREMENTS:
Travel
Up to 30%.
The expected salary range for this position based in California is $175,000 to $220,000 annually. Actual pay will be determined based on experience, qualification, geographic location, and other job-related factors. Company is posting role confidentially.
#J-18808-Ljbffr