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Data Management Regulatory Compliance Lead
2 weeks ago
Quality System Development
* Develop and implement quality standards and procedures in related systems and processes.
* Collaborate with internal and external stakeholders to ensure compliance with global GCP/GVP/GLP regulations.
Audit Management
* Lead and conduct internal and external audits related to GCP/GVP/GLP.
* Ensure the integrity and quality of study data by managing and participating in audits.
Risk Management
* Provide management with analysis and risk management reports for compliance and quality-related matters.
Qualifications
We are seeking an individual with extensive knowledge of the pharmaceutical/biotech industry centered on FDA, EU, ICH, GCP/GVP/GLP. The ideal candidate should possess exceptional organizational, interpersonal, and communication skills, as well as attention to detail and the ability to work collaboratively with project teams and cross-functionally. A Bachelor's or equivalent degree in a scientific discipline and 10+ years of relevant experience, or an advanced degree and 7+ years of relevant experience, are required.