Head of Compliance Operations

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Job Description

OBJECTIVES:

Provides strategic direction in establishing and maintaining mechanism to monitor the health of the quality compliance activities across Clinical Pharmacovigilance Medical Quality (CPMQ) team, including mechanism for the teams to identify systematic quality compliance risks and implementation of robust mitigation plans.

Provides direction in establishing and maintaining internal functional processes and systems to enable optimisation in the execution and oversight of Clinical and Safety Quality Compliance activities.

Engage with Global Quality & R&D quality compliance teams and share insights on continuous improvement that are enterprise-wide. Engage and provide direction to CPMQ on quality compliance activities.

Key member of the Leadership Team, contributing to the design, implementation and advancement of the Clinical and Safety Quality Compliance strategy, model and operations.

Leads and develops the Compliance operations team for the Clinical and Safety Quality Compliance operational activities. Promote and foster a culture of learning and continuous improvement across CPMQ.

ACCOUNTABILITIES:

• Provides strategic direction in establishing and maintaining mechanism to monitor the health of the quality compliance activities across Clinical Pharmacovigilance Medical Quality (CPMQ) team, including mechanism for the teams to identify systematic quality compliance risks and implementation of robust mitigation plans.

• Provides direction in establishing and maintaining internal functional processes and systems to enable optimisation in the execution and oversight of Clinical and Safety Quality Compliance activities.

• Engage with Global Quality & R&D quality compliance teams and share insights on continuous improvement that are enterprise-wide. Engage and provide direction to CPMQ on quality compliance activities.

• Leads the development, implementation, and refinement of functional quality compliance processes and systems, ensuring alignment with Global Quality and R&D Quality processes.

• Provide strategic direction on escalation pathways for significant non-compliance process and system issues and or risks. Ensuring appropriate mitigation actions and communication across CPMQ.

• Accountable for embedding and implementing new & revised Global Quality and R&D quality procedures across CPMQ.

• Ensure CPMQ teams have the necessary processes and systems in place to enable operational excellence through simplified, fit-for-purpose, end-to-end functional processes and tools that meet regulatory requirements and that expectations are aligned with the global processes for safety and clinical quality.

• Create mechanism to collate, trend and interpret quality data for actionable insights across CPMQ. Ensure the proactive monitoring of the health of the QMS and the sharing of compliance metrics for CPMQ activities e.g. audit, inspection, QE CAPA etc

• Establish mechanism for promoting process and system enhancements and for collating and sharing best practices e.g. Inspection, Audit learnings, Serious Breaches etc.

• Ensure the compliance team provides expertise and guidance across CPMQ for GCP, PV inspections. Embed the best practices into learning opportunities across CPMQ teams.

• Lead the team to be Stewards of the QMS within CPMQ (e.g. Quality Events, Serious Breach, Change Control, Risk Register, Regulatory Intelligence, Gap Assessment, Audits, Inspections, CAPA, SOP management, training assignment etc)

• Lead the Clinical and Pharmacovigilance Quality council.

• Key member of the Leadership Team, contributing to the design, implementation and advancement of the Clinical and Safety Quality Compliance strategy, model and operations.

• Leads the Compliance team, ensuring optimized resourcing, robust talent development and succession planning measures are in place to promote organizational growth/elevate capabilities.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BSc in a scientific or allied health/medical field (or equivalent degree).

• Minimum of 8 years of increasing responsibility and relevant experience in the global pharmaceutical industry, with at least 5 years of Quality/Compliance experience.

• Advanced knowledge of clinical research and pharmacovigilance throughout R&D and commercialization, and relevant regulations including GCP/GVP.

• Experience must include development and implementation of audit program, hosting/leading regulatory inspections, investigation and remediation activities on a global level and successful management of business transformation/change management initiatives e.g. quality system integration, outsourcing strategy etc

• Excellent communication skills to convey message. Exceptional active listening skills to understand the needs and concerns of others, which is crucial for finding win-win solutions.

• Outstanding ability to apply critical thinking and problem-solving abilities to address challenges and advocate for solutions.

• Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues.

• Fluency in written and spoken English, additional language skills a plus.

PHYSICAL DEMANDS:

• Routine demands of an office-based environment

TRAVEL REQUIREMENTS:

• Willingness to travel to various meetings, including overnight trips. Some international travel may be required.

Takeda Compensation and Benefits Summary

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EEO Statement

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