Director, Clinical and Safety Quality Assurance

3 days ago

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Agilent Technologies

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Diagnostics & Genomics • Chemical Analysis • Life Sciences • Environmental & Forensics • Food Safety

10,000+

💰 Post-IPO Debt on 2019-09

Description

• Reporting to the Vice President of the Diagnostics and Genomics (DGG) Quality organization within Global Quality and Regulatory Affairs (GQRA), the Director of Clinical and Safety Quality Assurance will be responsible for setting strategy for and leading the Clinical and Safety Quality Assurance function for Agilent. • You will ensure that Agilent’s processes for clinical quality oversight of clinical trial conduct, clinical trial sites, and suppliers, as well as vigilance oversight of product quality issues are robust and in alignment with ICH E6, other applicable Good Clinical Practice (GCP) and Good Vigilance Practice (GVP) regulatory requirements, and Agilent processes. • Emphasizing and embedding quality in the execution of clinical trials and vigilance activities assures patient safety, maintains data integrity, fosters regulatory compliance, and contributes to the overall success of in vitro diagnostics development programs. • Develop, implement, and ensure continuous improvement of the clinical and safety quality assurance strategy ensuring compliance with applicable regulations, industry standards, and company polices. • Lead a robust audit program to include investigator sites, vendors, clinical study reports, clinical trial master files, vigilance reporting, and other relevant internal processes in coordination with the Global Quality Compliance and Systems Internal Audit function.

Requirements

• Bachelor’s degree required, preferably in Biology, Chemistry, Nursing, Pharmacy, or other medical science degree combined with equivalent technical experience. • Minimum of 5 years' experience formally or informally leading people, projects and/or programs. • 5+ years industry experience in any combination of pharmaceutical, device, combo/device, research, development, clinical research, pharmaceutical manufacturing, quality systems, or a combination of those or comparable experiences. • Tactical and strategic clinical and safety quality assurance experience required. • Quality assurance, quality systems, and/or quality compliance background experience are highly desirable. • Thorough understanding of global requirements for conducting clinical trials involving in vitro diagnostics and detecting and reporting product safety issues. • Exceptional leadership and team building skills, ideally having integrated diverse global teams into a united organization sharing a common vision and mission. • Experience driving significant process improvement efforts.

Benefits

• eligibility for bonus • stock • benefits