Executive Director, QMS & Digital Greater Boston, MA Area

The Company is seeking an Executive Director for QMS and Digital. This senior leadership role is pivotal in ensuring the effectiveness, compliance, and continuous improvement of the Quality Management System (QMS) within a commercial-stage biotechnology organization. The successful candidate will be responsible for the strategy, governance, and integration of the QMS, serving as the enterprise Quality owner. Key responsibilities include leading core QMS processes, establishing governance and performance management, and driving Quality process excellence. The role also involves developing and executing the digital strategy, owning the Quality metrics and data infrastructure, and providing leadership in computerized system validation and data integrity. Applicants must have a Bachelor’s degree (advanced degree preferred) with over 15 years of Quality experience in the life sciences industry, including more than 8 years in GMP. Deep expertise in QMS strategy, governance, and core Quality processes is essential, as is a strong knowledge of global GxP requirements. The ideal candidate will have a proven track record in Quality process excellence, digital transformation, and experience with emerging AI technologies in regulated environments. Strong leadership, communication, and change-management skills are required, along with the ability to influence stakeholders and ensure the practical execution of Quality strategies. The role demands a strategic thinker with the ability to balance compliance, Quality risk, and business needs, and the candidate should be prepared for domestic and international travel.

Hiring Company

Ardelyx, Inc.