Otsuka America Pharmaceutical Inc.
Executive Director of R&D Global Quality (Remote)
Otsuka America Pharmaceutical Inc., Helena, Montana, us, 59604
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 be responsible for providing a compelling vision for the R&D Global Quality that aligns, supports and complements that of the Global Quality function. The leader shall provide guidance, strategic direction, and leadership to the Global Quality function with responsibilities for Global Clinical Quality (GCQ), CSV and GPV. In this role, the leader oversees R&D Global Quality for Otsuka and partners with the 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. Note:
The original language is preserved; formatting has been adjusted for clarity. Job Description
We are seeking a capable leader to inspire and develop a team of Quality professionals, partner closely with key stakeholders, and assist in the development and delivery of the Global Quality (GQ) strategy. Ensure internal and external sites are inspection ready, provide resources on site and/or remotely during health authority inspections, respond to observational findings within required timeframes, and implement CAPAs with effectiveness checks to prevent recurrence. Analyze findings to address systemic trends and improve efficiency and effectiveness. Lead clinical facility and system audits at facilities, investigator sites, and vendors (including contract research organizations); communicate audit results and ensure timely corrective actions are implemented and documented. Establish standards and procedures to ensure the business units quality management and compliance program are effective in identifying, detecting, and correcting non-compliance and mitigating risks. Report Quality Systems and Risks to Senior Management through Management Review to align with policy and strategy and gain consensus on risk mitigation. Key Responsibilities
Inspection Readiness:
Ensure continuous inspection readiness across all clinical trial sites, clinical and PV operations. Audit Management:
Plan, execute, and follow up on internal and external audits to ensure regulatory compliance. Regulatory Authority Engagement:
Act as primary liaison with regulatory authorities, facilitating Clinical and PV inspections and addressing findings. Data Integrity:
Ensure 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 Development:
Develop and maintain policies, systems and procedures describing internal processes for quality management and compliance with applicable regulations and guidelines to ensure sustained GCP/QSR compliance. Vendor Management:
Lead and develop systems for Clinical vendor management and oversight. Management Review:
Ensure R&D Management Reviews are conducted per QSR and Company requirements. Budget Management:
Develop and manage departmental budgets. Qualifications/ Required
Knowledge/ Experience and Skills: Qualifications
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; current audit techniques and government regulatory inspection procedures Experience with Japanese business context or a Japanese-arm multinational is required Experience in global pharmaceutical and medical device industries Experience working with external service providers Working knowledge of current Good Manufacturing Practice (cGMP) regulations Strong project management, leadership, problem solving, and organizational skills High emotional intelligence Exceptional leadership and team development skills Excellent communication and interpersonal skills Ability to collaborate with cross-functional teams Strategic thinking and problem-solving abilities Travel approximately 30% Competencies
Accountability for Results: Stay focused on key strategic objectives, be accountable for high standards of performance, and lead change Strategic Thinking & Problem Solving: Consider long-term impact on customers, patients, employees, and the business Patient & Customer Centricity: Focus on needs of customers and stakeholders Impactful Communication: Communicate with clarity and respect, influence at all levels Respectful Collaboration: Value diverse perspectives and partnerships Empowered Development: Support ongoing professional development Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: Salary range for candidates; other elements may apply based on experience and internal benchmarks. Information provided in accordance with laws. Company benefits : Comprehensive medical, dental, vision, prescription coverage, life, disability insurance, tuition reimbursement, student loan assistance, 401(k) match, PTO, paid holidays, and other benefits. More details at the official career site. Disclaimer: This job description describes the general nature and level of work; it is not exhaustive. Otsuka reserves the right to amend responsibilities as needed. Otsuka is an equal opportunity employer. All qualified applicants will be considered without regard to race, color, sex, gender identity, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or other protected characteristics. If you are a qualified individual with a disability, you may request accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com). Statement Regarding Job Recruiting Fraud Scams: At Otsuka, security of your information is important. Do not provide financial information during application. Only use official Otsuka Career site for application. Otsuka will not ask for money, financial details, or to download third-party apps in the application process. If you suspect a scam, contact Otsuka’s call center or report to authorities.
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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 be responsible for providing a compelling vision for the R&D Global Quality that aligns, supports and complements that of the Global Quality function. The leader shall provide guidance, strategic direction, and leadership to the Global Quality function with responsibilities for Global Clinical Quality (GCQ), CSV and GPV. In this role, the leader oversees R&D Global Quality for Otsuka and partners with the 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. Note:
The original language is preserved; formatting has been adjusted for clarity. Job Description
We are seeking a capable leader to inspire and develop a team of Quality professionals, partner closely with key stakeholders, and assist in the development and delivery of the Global Quality (GQ) strategy. Ensure internal and external sites are inspection ready, provide resources on site and/or remotely during health authority inspections, respond to observational findings within required timeframes, and implement CAPAs with effectiveness checks to prevent recurrence. Analyze findings to address systemic trends and improve efficiency and effectiveness. Lead clinical facility and system audits at facilities, investigator sites, and vendors (including contract research organizations); communicate audit results and ensure timely corrective actions are implemented and documented. Establish standards and procedures to ensure the business units quality management and compliance program are effective in identifying, detecting, and correcting non-compliance and mitigating risks. Report Quality Systems and Risks to Senior Management through Management Review to align with policy and strategy and gain consensus on risk mitigation. Key Responsibilities
Inspection Readiness:
Ensure continuous inspection readiness across all clinical trial sites, clinical and PV operations. Audit Management:
Plan, execute, and follow up on internal and external audits to ensure regulatory compliance. Regulatory Authority Engagement:
Act as primary liaison with regulatory authorities, facilitating Clinical and PV inspections and addressing findings. Data Integrity:
Ensure 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 Development:
Develop and maintain policies, systems and procedures describing internal processes for quality management and compliance with applicable regulations and guidelines to ensure sustained GCP/QSR compliance. Vendor Management:
Lead and develop systems for Clinical vendor management and oversight. Management Review:
Ensure R&D Management Reviews are conducted per QSR and Company requirements. Budget Management:
Develop and manage departmental budgets. Qualifications/ Required
Knowledge/ Experience and Skills: Qualifications
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; current audit techniques and government regulatory inspection procedures Experience with Japanese business context or a Japanese-arm multinational is required Experience in global pharmaceutical and medical device industries Experience working with external service providers Working knowledge of current Good Manufacturing Practice (cGMP) regulations Strong project management, leadership, problem solving, and organizational skills High emotional intelligence Exceptional leadership and team development skills Excellent communication and interpersonal skills Ability to collaborate with cross-functional teams Strategic thinking and problem-solving abilities Travel approximately 30% Competencies
Accountability for Results: Stay focused on key strategic objectives, be accountable for high standards of performance, and lead change Strategic Thinking & Problem Solving: Consider long-term impact on customers, patients, employees, and the business Patient & Customer Centricity: Focus on needs of customers and stakeholders Impactful Communication: Communicate with clarity and respect, influence at all levels Respectful Collaboration: Value diverse perspectives and partnerships Empowered Development: Support ongoing professional development Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: Salary range for candidates; other elements may apply based on experience and internal benchmarks. Information provided in accordance with laws. Company benefits : Comprehensive medical, dental, vision, prescription coverage, life, disability insurance, tuition reimbursement, student loan assistance, 401(k) match, PTO, paid holidays, and other benefits. More details at the official career site. Disclaimer: This job description describes the general nature and level of work; it is not exhaustive. Otsuka reserves the right to amend responsibilities as needed. Otsuka is an equal opportunity employer. All qualified applicants will be considered without regard to race, color, sex, gender identity, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or other protected characteristics. If you are a qualified individual with a disability, you may request accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com). Statement Regarding Job Recruiting Fraud Scams: At Otsuka, security of your information is important. Do not provide financial information during application. Only use official Otsuka Career site for application. Otsuka will not ask for money, financial details, or to download third-party apps in the application process. If you suspect a scam, contact Otsuka’s call center or report to authorities.
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