Director, Clinical and Safety Quality Assurance

Job 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. 

Patient needs, stakeholder demands, industry innovation, regulatory landscape, and Agilent’s evolved business strategy are complex and dynamic. 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. An elevated, focused, and evolved Good Clinical Practice (GCP) and Good Vigilance Practice (GVP) strategy and pipeline partnership are essential.

You will be a key member of the DGG Quality leadership team and will work in close partnership with the DGG Quality leaders to execute the multi-year GQRA strategic roadmap.

• 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.

• Support regulatory inspections, ensuring preparedness and appropriate responses to findings and observations through the quality management system.  Develop lessons learned from regulatory inspections and promote knowledge management. 

• Escalate issues of potentially critical non-compliance and lack of urgency in remediation to senior management. Analyze results, quality issues and investigation to identify actionable trends and to promote a state of compliance.

• Utilize industry leading clinical and safety quality assurance techniques and approaches while maintaining compliance and efficiency in related operational processes. Develop strategies to identify and mitigate related risks across GCP and GVP activities.

• Drive the strategic planning process for the Clinical and Safety Quality Assurance organization through ongoing assessment of regulatory, industry, technological, and internal trends/best practices, determining impact to the business.

• Develop and implement clinical and safety quality risk management strategies to identify, assess, and mitigate risks associated with clinical operations. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation.

• Drive effective and efficient execution of clinical quality assurance projects/initiatives including associated activities stemming from new project acquisitions, collaborations, mergers/acquisitions, CAPAs, and continuous improvement efforts.

• Establish and maintain robust clinical and safety quality standard operating procedures (SOPs), and other related quality documents. Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders.

• Provide leadership and oversight for training programs related to clinical and safety quality assurance. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures.

• Establish and monitor quality metrics and key performance indicators for the effectiveness of clinical and safety quality assurance activities. Prepare regular reports and presentations for executive management highlighting quality performance, trends, and areas for improvement.

• Drive a culture of continuous improvement in clinical and safety quality assurance. Provide insights to emerging regulations and requirements.  Identify areas for enhancement, implement process improvements, and promote best practices to enhance an overall culture of quality, efficiency, and compliance. 

Qualifications

• 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 forma