Clinical Quality Compliance Director
vor 2 Monaten
We are seeking a highly skilled and experienced Associate Director, Clinical Quality Compliance to join our team at Takeda. As a key member of our Clinical Quality Compliance function, you will be responsible for providing quality oversight to our clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management, and knowledge management.
Key Responsibilities- Partner with cross-functional teams to identify systemic quality and compliance risks, conduct investigations, and develop corrective and preventive actions (CAPAs).
- Lead the clinical trial delivery system inspection readiness program, including the implementation of a strategy to ensure inspection readiness and drive accountability and transparency.
- Provide insights on the latest regulatory requirements, operational and compliance metrics, and storyboards, and identify quality and compliance inspection risks.
- Host GCP inspections and provide strategic direction to relevant responsibilities and Subject Matter Experts (SMEs).
- Ensure a communication plan is in place to enable knowledge sharing of insights and risks, and communicate the progress of inspections daily.
- Lead the inspection response activities, ensuring responses are adequate, reviewed, and approved internally, and submitted on time.
- Oversee the completion and closure of inspection CAPAs, ensuring no CAPAs are late, and mitigate and escalate any risks.
- Be a Subject Matter Expert (SME) on Clinical Quality Compliance activities, including deviation management, quality investigation, CAPA management, and oversight, and represent Clinical Quality Compliance in these topics in inspections.
- Support and provide guidance on non-GCP specific inspections, such as GVP and GMP.
- Lead complex quality investigations to improve the clinical trial delivery systems, and provide Quality Leadership for other quality investigations.
- Develop lessons learned from regulatory inspections and quality investigations, and promote knowledge management.
- Lead improvement projects to ensure compliant quality systems in the clinical trial delivery quality systems.
- Approve controlled procedures related to clinical trial delivery quality systems to ensure regulatory and past inspection commitments are considered.
- Escalate issues of potentially critical non-compliance and lack of urgency in remediation to senior management.
- Develop and monitor relevant metrics and Main Performance/Quality Indicators (KPI/KQI), and mitigate, communicate, and escalate any risks flagged by the metrics/KQIs.
- Contribute to quality and compliance governance in Takeda, including the Clinical & Safety Quality Council, and communicate any quality or compliance risks and opportunities, continual improvements, and successes.
- BSc in a scientific or allied health/medical field (or equivalent degree).
- Minimum of 10 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 5 years of experience in GCP Quality/Compliance.
- Experience with pharmaceutical development, medical affairs, and GCP/GVP regulations, including FDA, EU, MHRA, PMDA, and ICH.
- Experience must include successful implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, and remediation activities on a global level.
- Experience managing complex organizational compliance issues and implementing organization-wide compliance projects.
Takeda is a patient-focused company that is transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We are committed to equitable pay for all employees and strive to be more transparent with our pay practices.
We offer a competitive salary range of $149,000 to $234,300, depending on qualifications and experience. Additionally, U.S. based employees may be eligible for short-term and/or long-term incentives, medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.
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Zürich, Zürich, Schweiz Takeda VollzeitAbout the RoleWe are seeking an experienced Associate Director, Clinical Quality Compliance to join our team at Takeda. As a key member of our Clinical Quality Compliance function, you will be responsible for providing quality oversight to our clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management,...
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Zürich, Zürich, Schweiz Takeda VollzeitAbout the Role:We are seeking an experienced Associate Director, Clinical Quality Compliance to join our team at Takeda. As a key member of our Clinical Quality Compliance function, you will be responsible for providing quality oversight to our clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management,...
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Zürich, Zürich, Schweiz Takeda VollzeitAbout the Role:We are seeking an experienced Associate Director, Clinical Quality Compliance to join our team at Takeda. As a key member of our Clinical Quality Compliance function, you will be responsible for providing quality oversight to our clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management,...
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