Director of QA & Compliance

About the Company

Expanding provider of clinical research site management services

Industry
Research

Type
Privately Held

About the Role

The Company is seeking a Director of Quality and Compliance to establish and maintain a robust quality program. The successful candidate will be responsible for evaluating, developing, and implementing standard operating procedures (SOPs) across all sites, as well as overseeing the quality management systems, training programs, and documentation processes. A key focus of the role is to ensure that the company's clinical research activities meet regulatory requirements and industry standards, with an emphasis on being "inspection ready at all times." The Director will also be involved in driving a culture of continuous quality and process improvement, leading and supporting staff during various audit activities, and serving as the primary point of contact for regulatory agencies and external auditors.Applicants for the Director of Quality and Compliance position at the company should have a Bachelor's degree in a related field, with a Master's degree preferred, and a minimum of 5 years' experience in quality and compliance roles within clinical research, particularly at the site level. The role requires in-depth knowledge of FDA regulations, ICH guidelines, and GCP standards, as well as experience in FDA inspections and sponsor audits. The ideal candidate will possess strong leadership and communication skills, the ability to influence and collaborate at all levels, and a passion for driving continuous improvement. Supervisory experience is a plus. The role demands a professional with the ability to balance quality with operational efficiency, create and deliver training at all levels, and work both independently and as part of a team. Meticulous attention to detail, the ability to maintain confidentiality, and a proactive approach to problem-solving are essential.

Travel Percent
Less than 10%

Functions

• Finance
• Operations