Assoc Director, Clinical and Safety Quality Compliance

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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.

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

Responsibilities

• 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.
• Maintain a robust communication plan that enables knowledge sharing of regulatory intelligence insights and risks across CPMQ.
• Implement change control and actions to address new and revised regulations and oversee review and closure of impact change controls.
• Provide data insights and identify quality and compliance risks and proactively provide strategic and tactical directions.
• 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 improvement projects.
• Support implementation of new and revised processes across CPMQ and present impact status to Global Quality and R&D Quality.
• Identify key areas for process improvements and develop and execute improvement plans according to timelines.
• Contribute to design, implementation and advancement of the Clinical and Safety Quality Compliance strategy and operations as a key member of the Leadership Team.

Qualifications

• BSc in a scientific or allied health/medical field (or equivalent degree).
• Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry in Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP Quality/Compliance.
• Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH.
• Experience in developing and implementing a clinical or pharmacovigilance audit program and hosting regulatory inspections, investigations and remediation activities on a global level.
• Experience managing complex organizational compliance issues and implementing organization-wide compliance initiatives.
• Skilled in managing global, cross‑functional projects.
• Successful management of business transformation/change management initiatives such as quality system integration, outsourcing strategy, etc.
• Excellent communication skills, exceptional active listening skills and outstanding critical‑thinking and problem‑solving abilities.
• Fluency in written and spoken English, additional language skills a plus.

Takeda Compensation And Benefits Summary: U.S. Base Salary Range $153,600.00 - $241,340.00.

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