Associate Director, Clinical Quality Compliance, Zürich

Vor 2 Tagen

Zürich, Schweiz TN Switzerland Vollzeit

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Client:

Takeda

Location:

Cambridge, MA

Job Category:

Other

Job Reference:

365b75b92a34

Job Views:

10

Posted:

21.01.2025

Expiry Date:

07.03.2025

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 operational activities, and building capabilities within the GCP Compliance function.

How You Will Contribute:

  • Partner with different functions contributing to 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 and driving accountability and transparency.
  • Provide insights to the latest requirements, operational and compliance metrics, and storyboards, identifying quality and compliance inspection risks.
  • Host GCP inspections and provide strategic direction to relevant responsibilities and Subject Matter Experts (SME).
  • Ensure a communication plan is in place for knowledge sharing of insights and risks.
  • Lead inspection response activities, ensuring timely and adequate responses are submitted.
  • Oversee the completion and closure of inspection CAPAs, ensuring no delays and appropriate effectiveness checks.
  • Be a Subject Matter Expert (SME) on Clinical Quality Compliance activities.
  • Support and provide guidance on non-GCP specific inspections (e.g., GVP, GMP).
  • Lead complex quality investigations to improve clinical trial delivery systems.
  • Develop lessons learned from regulatory inspections and promote knowledge management.
  • Lead improvement projects ensuring compliant quality systems in clinical trial delivery.
  • Approve controlled procedures related to clinical trial delivery quality systems.
  • Escalate critical non-compliance issues 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 increasing responsibility and 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 clinical or pharmacovigilance audit programs and leading regulatory inspections.
  • Experience managing complex organizational compliance issues.

Important Considerations:

  • May wear personal protective equipment (PPE) and other clean room garments.
  • Need to remove all make-up, jewelry, contact lenses, nail polish, and/or artificial fingernails 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 inspires and empowers you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence. We foster an inclusive, collaborative workplace.

Takeda Compensation and Benefits Summary

We are committed to equitable pay for all employees and strive to be 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.

U.S. based employees may be eligible for various benefits, including medical, dental, vision insurance, and a 401(k) plan.

EEO Statement

Locations:

Boston, MA; Zurich, Switzerland

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time

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