Takeda
Associate Director, Clinical Quality Compliance
Takeda, Boston, Massachusetts, us, 02298
Job Title : Associate Director, Clinical Quality ComplianceLocation : Cambridge, MAAbout the role:
As the Associate Director, Clinical Quality Compliance, you will provide quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management. You will maintain a state of control by implementing monitoring and control systems that ensure the quality systems supporting the clinical trial delivery are aligned with applicable regulations. You will report to and act as a strategic expert to the Head of GCP Quality Compliance in developing GCP Compliance strategies, managing operational activities, and building capabilities within the GCP Compliance function.How You Will Contribute:
Partner with different functions that contribute to the clinical trial delivery in identifying systemic quality and compliance risks, conducting investigations and developing adequate corrective and preventive actions (CAPAs).Lead the clinical trial delivery system inspection readiness program, ensuring inspection readiness, driving accountability and transparency.Provide insights to latest requirements, operational and compliance metrics, identify quality and compliance inspection risks, and provide tactical directions in the mitigation.Host GCP inspections and provide strategic direction to relevant responsibilities and Subject Matter Experts (SME).Ensure a communication plan is in place that enables knowledge sharing of insights and risks, and timely escalates to management.Lead inspection response activities, ensuring the responses are adequate and submitted on time.Oversee the completion and closure of inspection CAPAs, ensuring that no inspection CAPAs are late.Be a Subject Matter Expert (SME) on Clinical Quality Compliance activities including deviation management, quality investigation, and CAPA management.Support and provide relevant guidance to non-GCP specific inspections (e.g., GVP, GMP).Lead complex quality investigations improving the clinical trial delivery systems.Develop lessons learned from regulatory inspections and promote knowledge management.Lead improvement projects that ensure compliant quality systems in the clinical trial delivery quality systems.Approve controlled procedures related to clinical trial delivery quality systems.Escalate issues of potentially critical non-compliance to senior management.Develop and monitor relevant metrics and Main Performance/Quality Indicators (KPI/KQI).Contribute to relevant quality and compliance governance in Takeda.What you bring to Takeda:
BSc in a scientific or allied health/medical field (or equivalent degree).Minimum of 10 years of relevant experience in the global pharmaceutical industry, with at least 5 years in GCP Quality/Compliance.Experience with pharmaceutical development, medical affairs and GCP/GVP regulations.Experience in implementing a clinical or pharmacovigilance audit program.Experience managing complex organizational compliance issues and implementing compliance projects.Important Considerations:
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities. You may:Wear personal protective equipment (PPE) and other clean room garments daily.Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.Work in a cold, wet environment.Work multiple shifts, including weekends, or be asked to work supplemental hours.Work around chemicals that may require respiratory protection.More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
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As the Associate Director, Clinical Quality Compliance, you will provide quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management. You will maintain a state of control by implementing monitoring and control systems that ensure the quality systems supporting the clinical trial delivery are aligned with applicable regulations. You will report to and act as a strategic expert to the Head of GCP Quality Compliance in developing GCP Compliance strategies, managing operational activities, and building capabilities within the GCP Compliance function.How You Will Contribute:
Partner with different functions that contribute to the clinical trial delivery in identifying systemic quality and compliance risks, conducting investigations and developing adequate corrective and preventive actions (CAPAs).Lead the clinical trial delivery system inspection readiness program, ensuring inspection readiness, driving accountability and transparency.Provide insights to latest requirements, operational and compliance metrics, identify quality and compliance inspection risks, and provide tactical directions in the mitigation.Host GCP inspections and provide strategic direction to relevant responsibilities and Subject Matter Experts (SME).Ensure a communication plan is in place that enables knowledge sharing of insights and risks, and timely escalates to management.Lead inspection response activities, ensuring the responses are adequate and submitted on time.Oversee the completion and closure of inspection CAPAs, ensuring that no inspection CAPAs are late.Be a Subject Matter Expert (SME) on Clinical Quality Compliance activities including deviation management, quality investigation, and CAPA management.Support and provide relevant guidance to non-GCP specific inspections (e.g., GVP, GMP).Lead complex quality investigations improving the clinical trial delivery systems.Develop lessons learned from regulatory inspections and promote knowledge management.Lead improvement projects that ensure compliant quality systems in the clinical trial delivery quality systems.Approve controlled procedures related to clinical trial delivery quality systems.Escalate issues of potentially critical non-compliance to senior management.Develop and monitor relevant metrics and Main Performance/Quality Indicators (KPI/KQI).Contribute to relevant quality and compliance governance in Takeda.What you bring to Takeda:
BSc in a scientific or allied health/medical field (or equivalent degree).Minimum of 10 years of relevant experience in the global pharmaceutical industry, with at least 5 years in GCP Quality/Compliance.Experience with pharmaceutical development, medical affairs and GCP/GVP regulations.Experience in implementing a clinical or pharmacovigilance audit program.Experience managing complex organizational compliance issues and implementing compliance projects.Important Considerations:
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities. You may:Wear personal protective equipment (PPE) and other clean room garments daily.Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.Work in a cold, wet environment.Work multiple shifts, including weekends, or be asked to work supplemental hours.Work around chemicals that may require respiratory protection.More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
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