Associate Director, Document Control

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com . We are seeking an Associate Director to lead Corcept’s Document Control Program, an essential element of our Quality Management System (QMS). This leadership role requires a proven track record of advancing document control by remediating critical gaps, and implementing sustainable, risk-based controls that achieve GxP requirements. This role owns the strategy, execution, and compliance of the program and its supporting software. This leader champions a culture of SOP engagement, and accountability across departments, ensuring that stakeholders adhere to Corcept’s SOP standards. This involves communicating and coordinating SOP revisions involving everything from simple changes to complex system overhauls under compressed timeliness. This role requires a strong, focused leader who delivers high-visibility changes, drives implementation with resilience and clarity, and resolves obstacles and dynamic priorities. The leader communicates a clear and compelling vision, and guides teams through change using collaborative "come with me" leadership. The role requires pharmaceutical or biotechnology experience involving single product to multi-product transformation including the design of scalable business processes, modification of computer systems, and updating metadata. This is a hybrid role typically requiring on-site presence at least 3 days per week. Responsibilities: Lead and mentor a committed team of Document Control professionals, aligning through shared purpose, empowerment, and transparency. Foster a culture of ownership, agility, quality excellence, and professional growth Strengthen the Document Control Program and supporting software by remediating compliance risks, and architecting processes, metadata, and complex computer system configurations including security Evaluate and implement solutions to support a scalable, multi-product environment in compressed timelines resulting in a robust, inspection-ready program that achieves GxP standards Partner closely with Training program lead to integrate document process changes and system configuration changes to proactively address organizational change management of impacted personnel Assume software Business System Owner responsibilities, ensuring data and metadata maintenance and periodic system review Drive and manage high-volume SOP authorship, revision, and implementation — often under accelerated timelines Lead technical sessions as needed that elicit system requirements to scale Veeva QDS (QualityDocs) capabilities and ensure projects line up with Quality Systems project portfolio Establish and track key performance indicators (KPIs) to monitor and ensure system effectiveness, inspection readiness, and accountability Preferred Skills, Qualifications and Technical Proficiencies: Demonstrated success in leading organizational change management initiatives, including system and procedural overhauls Support compliance remediations by ensuring high volume of SOP changes are completed within abbreviated timelines Build effective partnerships across GxP departments including QA, Regulatory, IT, Manufacturing, and Development to build solutions Technical expertise as business owner of Veeva QDS with demonstrated success in transforming systems, associated business processes, and