CQA Team Leader

Job title :CQA Team Leader
Location: Remote, US

About the job

The CQA Team Manager (CQA TM) has direct management and supervisory responsibility of a team of auditors and is primarily responsible for ensuring the training, coaching, motivation and development of the individuals in his / her team. The CQA TM leads and inspires them to maximize their capabilities, performance and overall utility. By doing this the TM ensures that clinical projects are properly supported through independent clinical audit assessments, inspection management, quality reviews and GCP advice in relation to audit and inspection activities, that audit activities are effectively conducted, and ensures continuous improvement of the quality standards to meet regulatory requirements.

This position reports to the Head of Clinical Quality Assessment and is an active member of the management team for the group.

Join the engine of Sanofi ’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
About Sanofi :

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main responsibilities:
Strategic Risk Based Audits

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Oversees day-to-day performance of individuals ensuring appropriate coaching and training on ICH/GCP, relevant regulatory requirements and global, departmental and geographical QDs, policies and guidelines.

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Directly manages his/her team and business support staff, including objectives & performance management, individual development, administrative matters, and hiring as necessary. As part of the management team participates in the development of annual goals and objectives of the department.

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Directly leads and plays a key role in audit planning, actively participates in the development of the annual schedules and regular revisions of audit strategies.

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In collaboration with CQA Management team, contributes to the development, review and updates of the policies, procedures, guidelines and other standards, and ensures their implementation within his/her team

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Ensures appropriate implementation of planned audits and ensures his/her team resources are put to optimum use for all types of audits assigned, and ensures that skills are developed at team level.

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Responsible for the quality of the audits conducted by his/her team, including adequate conduct, reporting and follow-up of the audit activities as per departmental procedures, guidelines, etc. Ensures a quality driven risk-based approach to audit scope and reviews.

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Ensures the contribution of all members of his/her team to support key customers and provide GCP consultation in relation to audits and inspections, regulation interpretation and input / communication on functional or cross functional procedures. This includes support to internal and external clients for activities that support continuous improvement cycle such as Quality Reviews, participation in workgroups, etc.

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Participates in audits as needed with emphasis on complex objectives and/or as part of audit staff coaching, training, and assessment. During Investigator site audits, CQA Team Manager has direct access to subject individual data for records review and may have access to unblinded information/data. He/she is bound by professional secrecy and as such will not disclose any individual identity and/or individual medical information.

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Utilize predictive analytics and real-time data insights to identify potential risks and opportunities associated with clinical trials. Asses and escalate those risks as needed.

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Leader in determining the needs and des