Associate Director, Clinical Quality Compliance, Zürich District

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Client:

Takeda

Location:

Cambridge, MA

Job Category:

Other

Job Reference:

365b75b92a34

Job Views:

16

Posted:

06.03.2025

Expiry Date:

20.04.2025

Job Description:

Job Title : Associate Director, Clinical Quality Compliance

About 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 the operational activities of and building capabilities within the GCP Compliance function, and ensuring agreement on the CPMQ vision.

How You Will Contribute:

• Partner with different functions that contribute to clinical trial delivery in identifying systemic quality and compliance risks, conducting investigations, and developing adequate corrective and preventive actions (CAPAs), managing changes, and facilitating improvement in consideration of Takeda’s values and priorities.
• Lead the clinical trial delivery system inspection readiness program, including the implementation of a strategy. Engage with relevant responsibilities and partners to ensure inspection readiness, driving accountability and transparency.
• 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 (SME).
• Ensure a communication plan is in place that enables knowledge sharing of insights and risks. Communicate the progress of inspections daily, summarizing the inspection activities and potential observations and mitigation activities, and timely escalate to management.
• Lead the inspection response activities, ensuring the responses are adequate, reviewed, and approved internally by the relevant partners, at the right levels, and submitted on time.
• Oversee the completion and closure of inspection CAPAs, ensuring that no inspection CAPAs are late. Mitigate and escalate any risks. Ensure appropriate effectiveness checks are developed for relevant inspection CAPAs.
• Be a Subject Matter Expert (SME) on Clinical Quality Compliance activities including deviation management, quality investigation, corrective and preventive actions (CAPA) management, oversight, and change control.
• Support and provide relevant guidance to other 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 quality investigations. Promote knowledge management.
• Lead improvement projects that ensure compliant quality systems in 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). Mitigate, communicate, and escalate any risks flagged by the metrics/KQIs.
• Contribute to any relevant quality and compliance governance in Takeda, including the Clinical & Safety Quality Council, communicating any quality or compliance risks and opportunities, continual improvements, and successes.

What you bring to Takeda:

• 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 in implementing organization-wide 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 to ensure we are not endangering the quality of the product. 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 such as alcohol, acids, buffers, and Celite 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. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

#GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Base Salary Range:

$149,100.00 – $234,300.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. 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

Locations

Boston, MA; Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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