Otsuka America Pharmaceutical Inc.
Executive Director of R&D Global Quality (Remote)
Otsuka America Pharmaceutical Inc., Topeka, Kansas, United States, 66652
Overview
Job Summary We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for leading a global team focused on R&D Quality. This global role includes direct reports in the United States and dotted line reporting in Asia, Europe and North America. The leader of R&D Global Quality will ensure OAPI, OPDC and all affiliates are inspection ready, oversee clinical trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will provide a compelling vision for the R&D Global Quality that aligns with the Global Quality function and provides strategic direction for Global Clinical Quality (GCQ), CSV and GPV. The role oversees R&D Global Quality for Otsuka and partners with business groups and global regions to assure end-to-end Quality, harmonization of processes, and identification and mitigation of Quality risks from development through commercial registration and product distribution. Responsibilities
Inspection Readiness:
Ensure continuous inspection readiness across all clinical trial sites, clinical and Pharmacovigilance (PV) operations.
Audit Management:
Oversee the planning, execution, and follow-up of internal and external audits to ensure regulatory compliance.
Regulatory Engagement:
Act as the primary liaison with regulatory authorities, facilitating Clinical and PV inspections and addressing findings.
Data Integrity:
Ensure the accuracy, consistency, and reliability of clinical and PV data through robust Quality processes.
Team Leadership:
Lead, mentor, and develop a team of QA professionals, fostering a culture of excellence and continuous improvement.
Stakeholder Partnership:
Collaborate with key stakeholders to align QA activities with business objectives and regulatory requirements.
Policy & Compliance:
Develop and maintain policies, systems, and procedures for quality and regulatory compliance, ensuring sustained GCP/QSR compliance.
Vendor Management:
Lead and develop systems for clinical vendor oversight.
Management Review:
Ensure R&D Management Reviews are conducted per QSR and Company requirements.
Budget Management:
Develop and manage the departmental budget.
Qualifications
Experience & Skills Bachelor’s degree and 15+ years of experience in a FDA-regulated pharmaceutical and/or medical device industry environment.
Strong knowledge of current global Good Clinical Practice (GCP) for designing, recording, and reporting trials involving human subjects; audit techniques and regulatory inspection procedures.
Experience engaging with and/or within a Japanese company or a multinational with a Japanese arm (OPCJ business experience).
Experience in the global pharmaceutical and medical device industry and with external service providers.
Working knowledge of current Good Manufacturing Practice (cGMP).
Strong project management, leadership, problem-solving, and organizational skills; high emotional intelligence.
Exceptional leadership and team development, and excellent communication and interpersonal skills.
Ability to work collaboratively with cross-functional teams; strategic thinking and problem-solving abilities.
Travel approximately 30%.
Competencies
Accountability for Results
Strategic Thinking & Problem Solving
Patient & Customer Centricity
Impactful Communication
Respectful Collaboration
Empowered Development
Compensation & Benefits
Minimum $245,454.00 - Maximum $381,110.00, with incentive opportunity. Salary is determined based on experience, skills, and internal benchmarks. Company benefits include comprehensive medical, dental, vision, life insurance, disability coverage, tuition reimbursement, 401(k) match, flexible time off, paid holidays, and other benefits. Disclosures
Disclaimer:
This job description describes the general nature and level of work. Otsuka reserves the right to amend duties as needed. EEO Statement:
Otsuka is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. Accommodation:
Reasonable accommodations are available for applicants with disabilities. Contact Accommodation Request (EEAccommodations@otsuka-us.com). Fraud Notice:
Otsuka will never ask for financial information or payment during the application process. Only apply through the official Otsuka Career website and report suspicious activity to the appropriate authorities.
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Job Summary We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for leading a global team focused on R&D Quality. This global role includes direct reports in the United States and dotted line reporting in Asia, Europe and North America. The leader of R&D Global Quality will ensure OAPI, OPDC and all affiliates are inspection ready, oversee clinical trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will provide a compelling vision for the R&D Global Quality that aligns with the Global Quality function and provides strategic direction for Global Clinical Quality (GCQ), CSV and GPV. The role oversees R&D Global Quality for Otsuka and partners with business groups and global regions to assure end-to-end Quality, harmonization of processes, and identification and mitigation of Quality risks from development through commercial registration and product distribution. Responsibilities
Inspection Readiness:
Ensure continuous inspection readiness across all clinical trial sites, clinical and Pharmacovigilance (PV) operations.
Audit Management:
Oversee the planning, execution, and follow-up of internal and external audits to ensure regulatory compliance.
Regulatory Engagement:
Act as the primary liaison with regulatory authorities, facilitating Clinical and PV inspections and addressing findings.
Data Integrity:
Ensure the accuracy, consistency, and reliability of clinical and PV data through robust Quality processes.
Team Leadership:
Lead, mentor, and develop a team of QA professionals, fostering a culture of excellence and continuous improvement.
Stakeholder Partnership:
Collaborate with key stakeholders to align QA activities with business objectives and regulatory requirements.
Policy & Compliance:
Develop and maintain policies, systems, and procedures for quality and regulatory compliance, ensuring sustained GCP/QSR compliance.
Vendor Management:
Lead and develop systems for clinical vendor oversight.
Management Review:
Ensure R&D Management Reviews are conducted per QSR and Company requirements.
Budget Management:
Develop and manage the departmental budget.
Qualifications
Experience & Skills Bachelor’s degree and 15+ years of experience in a FDA-regulated pharmaceutical and/or medical device industry environment.
Strong knowledge of current global Good Clinical Practice (GCP) for designing, recording, and reporting trials involving human subjects; audit techniques and regulatory inspection procedures.
Experience engaging with and/or within a Japanese company or a multinational with a Japanese arm (OPCJ business experience).
Experience in the global pharmaceutical and medical device industry and with external service providers.
Working knowledge of current Good Manufacturing Practice (cGMP).
Strong project management, leadership, problem-solving, and organizational skills; high emotional intelligence.
Exceptional leadership and team development, and excellent communication and interpersonal skills.
Ability to work collaboratively with cross-functional teams; strategic thinking and problem-solving abilities.
Travel approximately 30%.
Competencies
Accountability for Results
Strategic Thinking & Problem Solving
Patient & Customer Centricity
Impactful Communication
Respectful Collaboration
Empowered Development
Compensation & Benefits
Minimum $245,454.00 - Maximum $381,110.00, with incentive opportunity. Salary is determined based on experience, skills, and internal benchmarks. Company benefits include comprehensive medical, dental, vision, life insurance, disability coverage, tuition reimbursement, 401(k) match, flexible time off, paid holidays, and other benefits. Disclosures
Disclaimer:
This job description describes the general nature and level of work. Otsuka reserves the right to amend duties as needed. EEO Statement:
Otsuka is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. Accommodation:
Reasonable accommodations are available for applicants with disabilities. Contact Accommodation Request (EEAccommodations@otsuka-us.com). Fraud Notice:
Otsuka will never ask for financial information or payment during the application process. Only apply through the official Otsuka Career website and report suspicious activity to the appropriate authorities.
#J-18808-Ljbffr