Strategic Quality Assurance Leader for Clinical Trial Delivery
vor 1 Monat
We are seeking a highly experienced Strategic Quality Assurance Leader to oversee the clinical trial delivery quality systems at Takeda. This individual will provide quality oversight, promote operational and compliance excellence, and maintain a state of control by implementing monitoring and control systems aligned with applicable regulations.
Key Responsibilities- Partner with various functions to identify systemic quality and compliance risks, conduct investigations, and develop adequate corrective and preventive actions (CAPAs), manage changes, and facilitate improvement that considers Takeda's values and priorities.
- Lead the clinical trial delivery system inspection readiness program, including strategy implementation. Engage with relevant responsibilities and partners to ensure inspection readiness, drive accountability, and transparency. Functions include Global Development Office, Data Science Institute, Global Regulatory Affairs, Procurement, and Legal.
- Provide insights into the latest requirements, operational and compliance metrics, and storyboards; identify quality and compliance inspection risks, and provide tactical directions in mitigation.
- Host GCP inspections and provide strategic direction to relevant responsibilities and Subject Matter Experts (SMEs).
- Evaluate the effectiveness of the inspection response activities, ensuring responses are adequate, reviewed, and approved internally by relevant partners at the right levels and submitted on time. Provide input to ensure the impact is thoroughly assessed, appropriate cause is identified, and measurable, achievable, time-bound CAPAs are developed.
- Oversight of completed and closed inspection CAPAs, ensuring no inspection CAPAs are late, mitigating and escalating any risks. Develop appropriate effectiveness checks for relevant inspection CAPAs, providing input to effectiveness check plans, and reviews/approving outcomes.
- Serve as a Subject Matter Expert (SME) on Clinical Quality Compliance activities, including deviation management, quality investigation, CAPA management, and oversight, and change control. Represent Clinical Quality Compliance in these topics during inspections.
- Support and provide guidance on non-GCP specific inspections (e.g., GVP, GMP).
- Conduct complex quality investigations, improving the clinical trial delivery systems. Provide Quality Leadership for other quality investigations, ensuring engagement of the right partners in impact assessment, root cause analysis, and CAPA development.
- Analyze results, quality issues, and investigations to identify applicable trends and promote a state of compliance.
- Develop and monitor relevant metrics and Key Performance/Quality Indicators (KPI/KQI). Mitigate, communicate, and escalate any risks flagged by metrics/KQIs, ensuring actions are commensurate to the risk and timely. Drive the development and execute the strategy to understand the health of the clinical trial delivery quality system.
- Contribute to quality and compliance governance in Takeda, including the Clinical & Safety Quality Council, communicating quality or compliance risks and opportunities, continual improvements, and successes.
Takeda is transforming patient care through novel specialty pharmaceuticals and best-in-class patient support programs. We foster an inclusive, collaborative workplace where our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
What You Bring- BSc in a scientific or allied health/medical field (or equivalent degree)
- Minimum 10 years of increasing responsibility and relevant experience in global pharmaceutical industry 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
- 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
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including qualifications, years of relevant experience, unique skills, level of education, certifications, and location.
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