BioSpace
Associate Director, Clinical Program Quality Investigations
BioSpace, Boston, Massachusetts, us, 02298
Associate Director, Clinical Program Quality Investigations
Associate Director, Clinical Program Quality Investigations is responsible for ensuring compliance of deviation management and serious breach process. This role focuses on defining activities, processes, and standards to meet quality requirements relevant to deviation management and serious breach. The position supports Takeda’s mission by maintaining high standards of quality and compliance in clinical trials. Responsibilities
Drive implementation of clinical deviation management and serious breach process across Clinical Program Quality. Act as subject matter expert (SME) for clinical deviation management and serious breach investigation and reporting to regulatory agencies. Partner strategically with Clinical Program Quality for complex clinical deviations and serious breaches. Review clinical deviations across studies, share insights and trend analysis with Clinical Pharmacovigilance, Medical Quality, and R&D Quality leadership for proactive risk mitigation and actions. Escalate quality issue trends to R&D Quality Leadership and R&D leadership. Ensure compliance with deviation management and serious breach procedures by providing expert advice to Clinical Program Quality. Ensure serious breaches are adequately assessed and reported within timelines. Lead the Clinical Program Quality and deviation management and serious breach review board meetings. Lead complex quality investigations impacting the clinical trial delivery systems. Provide quality leadership for serious breach quality investigations, ensuring right stakeholders are engaged in impact assessment, root cause analysis and CAPA development. Oversee the Serious Breach Reporting Service and ensure the service is executed as planned, including regular reconciliation of information. Provide data insights to Clinical Deviations and Serious Breaches to identify systematic quality and compliance risks, and proactively provide strategic and tactical directions in the mitigation. Actively participate and contribute to the design, implementation and advancement of the Clinical Program Quality strategy, model, and operations as a key member of Clinical Quality program leadership team. Qualifications
BSc in a scientific or allied health/medical field (or equivalent degree). Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP Quality/Compliance. Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH. Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, deviation management, serious breaches, investigations and remediation activities on a global level. Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives. Skilled in managing global, cross‑functional projects. Successful management of business transformation/change management initiatives (e.g., quality system integration, outsourcing strategy etc). Excellent communication skills to convey message. Exceptional active listening skills to understand the needs and concerns of others, crucial for finding win‑win solutions. Outstanding ability to apply critical thinking and problem‑solving abilities to address challenges and advocate for solutions. Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues. Compensation and Benefits
Location: Boston, MA U.S. Base Salary Range: $153,600.00 – $241,340.00 U.S. based employees may be eligible for short‑term and/or long‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state, local laws, and any other characteristic protected by law.
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Associate Director, Clinical Program Quality Investigations is responsible for ensuring compliance of deviation management and serious breach process. This role focuses on defining activities, processes, and standards to meet quality requirements relevant to deviation management and serious breach. The position supports Takeda’s mission by maintaining high standards of quality and compliance in clinical trials. Responsibilities
Drive implementation of clinical deviation management and serious breach process across Clinical Program Quality. Act as subject matter expert (SME) for clinical deviation management and serious breach investigation and reporting to regulatory agencies. Partner strategically with Clinical Program Quality for complex clinical deviations and serious breaches. Review clinical deviations across studies, share insights and trend analysis with Clinical Pharmacovigilance, Medical Quality, and R&D Quality leadership for proactive risk mitigation and actions. Escalate quality issue trends to R&D Quality Leadership and R&D leadership. Ensure compliance with deviation management and serious breach procedures by providing expert advice to Clinical Program Quality. Ensure serious breaches are adequately assessed and reported within timelines. Lead the Clinical Program Quality and deviation management and serious breach review board meetings. Lead complex quality investigations impacting the clinical trial delivery systems. Provide quality leadership for serious breach quality investigations, ensuring right stakeholders are engaged in impact assessment, root cause analysis and CAPA development. Oversee the Serious Breach Reporting Service and ensure the service is executed as planned, including regular reconciliation of information. Provide data insights to Clinical Deviations and Serious Breaches to identify systematic quality and compliance risks, and proactively provide strategic and tactical directions in the mitigation. Actively participate and contribute to the design, implementation and advancement of the Clinical Program Quality strategy, model, and operations as a key member of Clinical Quality program leadership team. Qualifications
BSc in a scientific or allied health/medical field (or equivalent degree). Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP Quality/Compliance. Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH. Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, deviation management, serious breaches, investigations and remediation activities on a global level. Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives. Skilled in managing global, cross‑functional projects. Successful management of business transformation/change management initiatives (e.g., quality system integration, outsourcing strategy etc). Excellent communication skills to convey message. Exceptional active listening skills to understand the needs and concerns of others, crucial for finding win‑win solutions. Outstanding ability to apply critical thinking and problem‑solving abilities to address challenges and advocate for solutions. Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues. Compensation and Benefits
Location: Boston, MA U.S. Base Salary Range: $153,600.00 – $241,340.00 U.S. based employees may be eligible for short‑term and/or long‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state, local laws, and any other characteristic protected by law.
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