Associate Director/Director, Quality Systems and Document Control

The primary role of the Associate Director/Director, QA Systems and Document Control is to lead the ongoing development, implementation, maintenance, and evaluation of quality management systems across the organization. The successful candidate will possess a strong background in quality management systems, regulatory compliance, and document control processes. This is a hybrid role.

• Continuously improve and implement quality policies, procedures, and objectives to achieve organizational goals.
• Take charge of leading and overseeing Quality Document Control processes.
• Analyze and present insights on quality metrics, trends, and overall performance.
• Spearhead initiatives to continually improve quality systems, pushing forward a culture of continuous improvement.
• Collaborate directly with all levels and departments within CymaBay to reinforce and support quality systems.
• Serve as the business system owner for Veeva Quality Docs, overseeing validation, implementation, and configuration changes. This includes testing new functionality and content for the quality docs platform.
• Ensure alignment with departmental management and the broader company vision.
• Facilitate support for regulatory inspections.
• Fulfill other responsibilities as assigned.

• A minimum of 5-7 years of pertinent experience in Quality, emphasizing quality systems and document control, including 3 years in a managerial role.
• Previous involvement in managing quality systems, encompassing paper-based, hybrid, and cloud-based systems.
• Demonstrated success in initiating and leading process improvement initiatives.
• Ability to effectively engage with a diverse, multi-disciplinary functional group.
• Strong change management skills, showcasing the capacity to simplify and enhance business processes.
• Adaptability to a dynamic, fast-paced, and intricate business environment.
• Proficient verbal and written communication skills in a practical context.
• Robust organizational skills coupled with meticulous attention to detail.
• Self-motivated and disciplined with a proactive approach.
• Excellent proficiency in computer applications, including MS Word, Excel, and PowerPoint.

• Bachelor of Science degree

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk and hear. The employee frequently is required to walk and sit. The employee is occasionally required to stand. The employee must occasionally lift and/or move up to 25 pounds.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate