Associate Director, Document Control

Role Summary

The Associate Director, Document Control leads Corcept’s Document Control Program as a core element of the Quality Management System. The role owns the strategy, execution, and compliance of the program and its supporting software, driving remediation of gaps and implementation of sustainable, risk-based controls that meet GxP requirements. It emphasizes SOP engagement across departments, timely revisions, and strong leadership through change, with on-site presence required 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

Qualifications

• Required: Demonstrated success in leading organizational change management initiatives, including system and procedural overhauls
• Required: Support compliance remediations by ensuring high volume of SOP changes are completed within abbreviated timelines
• Required: Build effective partnerships across GxP departments including QA, Regulatory, IT, Manufacturing, and Development to build solutions
• Required: Technical expertise as business owner of Veeva QDS with demonstrated success in transforming systems, associated business processes, and configuration from a single product to a multi-product and multi-geographical site system
• Required: Clear and concise written communication skills to align documentation to Quality Policy/Manual, using established Document Control tools to deliver consistent, quality written work
• Required: Inspirational leadership style with a proven ability to guide teams through complexity and ambiguity
• Required: Experienced in presenting to executive leadership and acting as a visible leader during audits and inspections
• Required: Excellent verbal and written communication skills with the ability to influence a wide range of stakeholders in various departments
• Required: Strong working knowledge of pharmaceutical GxP standards and their impact on SOPs, work instructions, and controlled documents
• Required: Designed applicable document control processes that integrate with GxP Training program
• Required: Extensive experience as Business System Owner of Veeva QDS
• Preferred: BA/BS degree in a scientific/technical/engineering field
• Preferred: 10+ years of experience in pharmaceutical or life sciences industry
• Preferred: Veeva certification

Education

• BA/BS degree in a scientific/technical/engineering field
• 10+ years of experience in pharmaceutical or life sciences industry
• Veeva certification