Quality Management Systems Director - Clinical Trial Services (BB-DB88B)
Found in: Neuvoo CA
As the Quality Management Systems Director you will have responsibility for shaping the Quality Management System (QMS), assuring compliance to applicable regulations and guidance, conducting audits and supporting Health Authority Inspections. You will report directly to the Vice President of Quality, and serve as the expert in Good Clinical Practice (GCP), to teams and sites.
You will develop and manage processes, based on data from metrics, audits and inspections
You will work with the Clinical Trial Services team and Sr. Management, to develop quality performance measurements
You will collaboratively work with the Director Quality Conduct, clinical trial teams, and sites to advise in conducting risk assessment and developing mitigation plans to ensure GCP compliance and inspection readiness
You will support due diligence and oversight of vendors and suppliers
8+ years of experience in the pharmaceutical, biotechnology or related health care industry.
4+ years of GCP-related Quality Assurance or relevant clinical trial experience
Clinical trial conduct
ICH GCP and applicable global regulations and guidance for clinical trial conduct and industry best practices.
Key Risk Indicators (KRI's), Key Quality Indicators (KQI's), Key Performance Indicators (KPI's), Quality Tolerance Limits.
Metrics and analytics
SOP's, Work Instructions, template development per good document management practices
Identify process deficiencies and continuous improvement programs
Host inspections, for global Health Authorities
Conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, patient safety and data integrity
Negotiate and communication
Write quality positions, and procedures.
Communicate complex issues in a simple way
Problem solve and resolve conflict
Negotiate and influence in a matrix environment
Communicate with audiences with varying knowledge levels of clinical trial conduct, Regulations and guidance
Analyze complex data
Adapt to changes in priorities
Translate strategy into action
Bachelor's Degree required; Master's Degree preferred
At CVS Health, we are joined in a common purpose: helping people on their path to better health. We are working to transform health care through innovations that make quality care more accessible, easier to use, less expensive and patient-focused. Working together and organizing around the individual, we are pioneering a new approach to total health that puts people at the heart.
We strive to promote and sustain a culture of diversity, inclusion and belonging every day. CVS Health is an equal opportunity and affirmative action employer. We do not discriminate in recruiting, hiring or promotion based on race, ethnicity, sex/gender, sexual orientation, gender identity or expression, age, disability or protected veteran status or on any other basis or characteristic prohibited by applicable federal, state, or local law. We proudly support and encourage people with military experience (active, veterans, reservists and National Guard) as well as military spouses to apply for CVS Health job opportunities.
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