This position is Responsible for leading Quality Assurance Department in accordance with vision, values, and strategic goals of the company. It will involve overseeing and facilitating efficient quality operations, assuring consistent client service, implementing laboratory practices as applicable to current regulatory standards, working with client and agency audits and correspondence, maintaining certifications, Quality Assurance policy development, and maintenance, following up promptly on any quality and compliance related issues, and implementing respective CAPA actions to assure adherence to the required quality metrics. Other responsibilities are as follows:
- Chairs Quality Management Oversight Meetings to monitor for trends, identify improvements, and assure the effectiveness of the Quality Management System
- Implements, prepares, and presents training programs as required to satisfy regulatory requirements
- Manages Quality Management System
- Applies industry experience to establish and implement best laboratory practices and quality system standards as related to compliance
- Performs QA review and approvals as required
- Maintains current records for required certifications and/or accreditations
- Communicates with client and agency auditors, responds to findings, and effectively addresses concerns or findings
- Provides information for monthly/quarterly reports to senior site management
- Identifies, implements, and assures adherence to effective quality control measures
- Mentors QA staff and provides leadership through demonstration of the vision, values, and strategic goals of the company
- Leads complex projects through to completion
- Communicates effectively with client staff members
- Performs other duties as assigned