Reporting to the NEIDL AVP for Research Compliance, this position is responsible for developing a comprehensive quality assurance and a management plan. The incumbent serves as a liaison between Researchers, Administration, Environmental Health and Safety, Research Occupational Health Program, Public Safety, Facilities and Emergency Response Planning Cores to ensure that critical quality assurance functions are performed according to developed Standard Operating Procedures (SOP) in a timely manner. The incumbent provides strategic direction and leadership to develop, implement, and oversee the NEIDL Institute quality management system consistent with BU institutional infrastructure. This includes the development of the quality management function objectives and performance plans including but not limited to those that address staffing, internal audit programs, training programs and mentoring of senior staff, as well as measurable metrics.
Some duties include but are not necessarily limited to;
The hours for this position will usually be 8am to 5pm. But this person will be expected to work off hours as well and will be expected to make themselves available when it is necessary.
- Work with Core Directors to develop quality assurance programs which are tailored to meet both the unique needs of each core and the broader NEIDL Institute.
- Develop quantitative indicators for core monitoring.
- Serve on, or provide leadership to, committees, task forces or other collaborative or oversight groups as assigned.
- Assist Core Directors with development of standard operating procedures (SOP’s).
- Develop and implement quality audit procedures.
- Provide guidance to Core Directors to assure that corrective actions are completed to insure conformance to core quality standards.
- Assist with the development of preventive maintenance compliance programs and schedules to ensure reliable delivery of core services.
- Establish and direct Quality Assurance training programs for investigators and staff.
- Oversee records management program to include qualifications for work in NEIDL, approved SOP’s, equipment calibration records, audit corrective actions etc.
- Manage validation program to include equipment installation and calibration, including recommendations for equipment replacement when indicated.
- Must have a Master’s of Science in either life sciences, engineering, or a related discipline and at least ten years experience in the development and maintenance of quality management systems in related fields such as university, biotechnology, or pharmaceutical industry.
- Demonstrated ability to lead and influence others in a matrix management structure with five to seven years in a direct managerial role.
- Excellent written and verbal communication skills with different functional groups across all levels of the organization.
- Ability to develop and maintain a strong, cross-functional quality team.
- Ability to objectively evaluate processes and procedures.
- Thorough knowledge of management systems and accreditation requirements
- Knowledge of high containment laboratories or clean room environment a plus
- Knowledge of International Quality Management Systems (i.e. ISO, CEN, etc)