Define and execute the Quality System that regulates Fortrea Clinical Services
Develop and implement a global QA strategy aligned with corporate goals and regulatory expectations
Ensure adherence to global regulations through the creation and completion of a strong quality risk framework of annual audits.
Represent Regulatory Compliance & Quality Assurance on all potential mergers/acquisitions, along with the subsequent integrations of the target entity.
Serve as a key member of the extended leadership team, contributing to overall business strategy and risk management
Partner with the business leaders to implement and oversee the quality system, ensuring a collaborative approach to driving a strong culture of quality.
Develop proactive measures to mitigate quality-related risks and maintain compliance with global regulatory bodies with the Fortrea Clinical Services business leaders
Identify and implement continuous improvement initiatives to enhance operational and QA efficiency and reduce risks
Build, lead, and mentor a high-performing global QA team
Oversee the QA team to serve as the primary contact in regulatory inspections and audits of Fortrea
Establish Key Quality Metrics/Indicators, analyze trends, and report findings to executive leadership for informed decision-making
Requirements
Advanced degree in Life Sciences preferred.
Proven leadership experience in a global QA role
In-depth knowledge of ICH-GCP, FDA, EMA, and other international regulatory standards
Experience directing global audits and regulatory inspections
Experience leading global teams
Minimum 15 years of experience in clinical QA within a CRO, pharmaceutical, or biotech environment
20 years of experience in the clinical research industry
Benefits
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