Manager/Sr. Manager, Clinical GCP Quality Assurance

About the Role

Day-to-day responsibilities will include providing strategic and operational leadership in planning and executing GCP Quality activities, maintaining current knowledge of clinical quality guidance and regulations, and demonstrating excellent communication and people skills. The successful candidate will be part of a global team, working closely with clinical, regulatory, and quality teams to drive company initiatives and policies.

The role is based in the United States, but the company has a global presence with locations in five countries, offering opportunities for collaboration and knowledge sharing across different cultures and regulatory environments.

What You Will Do

• Provide strategic and operational leadership in the planning and executing of GCP Quality activities
• Successfully lead global and cross-functional quality projects
• Maintain current knowledge of ever-changing clinical quality guidance and regulations
• Ensure compliance to regulations, oversee quality management systems, and interact directly with cross-functional clinical, regulatory, and quality teams
• 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
• Direct experience in successfully managing and overseeing CAPA plans
• Conduct and manage sites, internal GCP, and vendor audits, as well as direct and guide audit follow-up actions
• Establish Quality and Cross-Functional teams

What We Are Looking For

• At least 10 years of experience in clinical quality, process improvement, regulatory inspection management
• At least two years of clinical auditing experience as a lead auditor
• Excellent working knowledge of Good Clinical Practices (ICH E6), quality requirements, and other international regulations
• Experience in clinical inspection readiness and acting as the point person for sponsor clinical inspections
• Strong leadership and communication skills
• Ability to implement and collaboratively drive company initiatives and policies
• Experience with Excel and other quality management tools

Nice to Have

• Experience in the biotech or pharmaceutical industry
• Knowledge of precision medicine and cell-targeting therapies
• Experience working in a global company with multiple locations
• Certification in clinical quality assurance or a related field

Benefits and Perks

• Competitive salary and benefits package
• Opportunity to work with a global company and make a significant impact in the biotech industry
• Collaborative and dynamic work environment
• Professional development and growth opportunities
• Remote work options and flexible working hours
• Access to the latest technologies and tools in clinical quality assurance

• Ensure your resume and cover letter are tailored to the clinical quality assurance field, highlighting your experience with Good Clinical Practices and regulatory compliance.
• Prepare to talk about your experience with CAPA plans, audit management, and inspection readiness during the interview.
• Research Rakuten Medical, Inc.'s mission and values to understand the company culture and how you can contribute to it.
• Be ready to discuss your experience with quality management systems and how you have implemented them in previous roles.
• Consider reaching out to current or former employees to gain insight into the company's work environment and expectations.
• Practice your communication and leadership skills, as they are essential for success in this role.
• Review the company's website and social media to stay up-to-date with the latest news and developments.