The Quality Assurance and Regulatory Affairs Manager (QA/RA Manager) is responsible for implementing, overseeing, and ensuring ongoing compliance with regulatory affairs and quality assurance requirements and regulations. The QA/RA Manager is also responsible for interacting and leading the Quality Assurance & Regulatory Affairs teams to accomplish the business objectives and performing to operational objectives. The QA/RA Manager must monitor and ensure implementation of goals to meet established quality assurance, quality control, and quality improvement. This role will also be responsible for facilitating FDA inspections, including quality evaluations as well as ensuring compliance with regulatory agency requirements through maintaining proper documentation, conducting audits, and corrective actions. This position requires an appropriate level of accountability for decision making and clear communication skills.

The position includes all other responsibilities that may be necessary to fulfill the duties associated with the position or as may be assigned.

QUALIFICATIONS

WORK CONDITIONS AND PHYSICAL REQUIREMENTS

The Quality Assurance and Regulatory Affairs Manager may require working additional hours to meet project deadlines and will travel occasionally to attend seminars, conferences, or trainings.

DIRECT REPORTS

This position provides work direction and gives input on hiring, promotions, transfers, performance management, discipline, and termination.

Note: The Company will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job.