Assoc Director, Clinical and Safety Quality Compliance

Associate Director, Clinical and Safety Quality Compliance

The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality of processes and product outputs. This role involves defining and specifying activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards, this role supports Takeda's mission to provide better health and a brighter future.

This role can be located in Cambridge, MA or Zurich, Switzerland and is Hybrid (not remote). Relocation Benefit is available to support your transition.

How will you contribute :

• Ensure compliance to Regulatory Intelligence Procedures by executing the regulatory intelligence process in partnership with functional compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and procedures and determined by compliance to regulatory intelligence procedures.
• Ensures a robust communication plan is in place (including brief description of the new and or revised regulations the impact, any risks, mitigation plans, timelines) that enables knowledge sharing of regulatory intelligence insights and risks across CPMQ. Communicates to CPMQ periodically the progress of new and revised regulations and impact.
• Ensure implementation of change control and actions completed to address new and revised regulations. Oversees the review, completion and closure of routine and complex, impactful strategic clinical-related change controls and strategic Pharmacovigilance-related change controls.
• Provides data insights to emerging regulations and requirements, operational and compliance metrics and storyboards, identifies quality and compliance risks, and proactively provides strategic and tactical directions in the mitigation.
• Actively participate and contribute to enterprise-wide projects and initiatives, ensuring insights related to clinical and safety quality are considered.
• Enable a compliant quality system in safety and clinical trial delivery systems via CPMQ continual improvements projects. Actively participate and represent in continual improvement projects, related to safety and clinical trial delivery in partnership with GDO, PSPV, GRA etc. Review the outputs of the safety and clinical trial delivery redesigned processes and coordinate CPMQ colleague's input.
• Provide CPMQ insights on continuous improvement that are enterprise-wide (ie Veeva, QMS, Enterprise Audit, etc.) to Global Quality and R&D Quality. Present to CPMQ at periodic intervals the status, insights and impact of projects impacting clinical and safety quality.
• Actively identifies key areas for process improvements and develop and execute plans according to timelines. Support the implementation of new and revised processes across CPMQ.
• Contributing to the design, implementation and advancement of the Clinical and Safety Quality Compliance strategy, model, and operations as a key member of the Leadership Team.

What you bring to Takeda :

Locations : Boston, MA, CHE - Glattpark (Opfikon) - Zurich HQ

Worker Type : Employee

Worker Sub-Type : Regular

Time Type : Full time

Job Exempt : Yes