Director of Quality
- Location: Clarksville, IN
- Working situation: Hybrid
- Level: Director
Our client, an expanding PCR-based Infectious Disease laboratory is looking to add to their Quality team!
The Director of Quality will help lead the Quality Operations team and oversee clinical laboratory testing, the quality system of the laboratory and study execution. This individual will work to foster a culture of quality through providing leadership and guidance to their team and company.
The Director of Quality will:
- Play a leadership role within the lab QA department that assists with planning, implementing, and monitoring the Quality Management System (QMS).
- Collaborate cross-functionally for Quality Assurance updates, education, and updating/reviewing any CLIA regulations.
- Participates in internal/external audits (CAP)
- All instrumentation/platform and all sample matrices/collection devices will undergo vigorous validation to meet the CAP /NYDOH and CA regulatory needs for all physical sites under the administration.
- Directs, coordinates, and oversees quality activities and projects to ensure that services are provided on schedule within quality and cost objectives.
The Director of Quality has the following qualifications:
- Master's degree or PhD in Biological sciences and/or training in a commercial, clinical, environmental, analytical, or genetic laboratory environment
- Minimum of 8 years of related industry experience
- Knowledge of CAP, CLIA and NYS DOH