Associate Director, Document Control

Role Summary

Associate Director, Document Control responsible for leading Corcept’s Document Control Program within the Quality Management System (QMS). Owns strategy, execution, and compliance of the program and its supporting software, remediating gaps, and implementing sustainable, risk-based controls to meet GxP requirements. Champions SOP engagement across departments and guides teams through change with a collaborative leadership approach. This role requires pharmaceutical or biotechnology experience and a hybrid on-site presence (typically at least 3 days per week).

Responsibilities

• Lead and mentor a team of Document Control professionals, fostering 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, achieving an inspection-ready program that meets GxP standards
• Partner with Training to integrate document process changes and system configuration changes for organizational change management
• 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 under accelerated timelines
• Lead technical sessions to elicit system requirements to scale Veeva QDS capabilities and align projects with Quality Systems portfolio
• Establish and track KPIs to monitor system effectiveness, inspection readiness, and accountability

Qualifications

• Preferred: Demonstrated success in leading organizational change management initiatives, including system and procedural overhauls
• Preferred: Ability to support compliance remediations with high volumes of SOP changes completed within shortened timelines
• Preferred: Build partnerships across QA, Regulatory, IT, Manufacturing, and Development to build solutions
• Preferred: Technical expertise as business owner of Veeva QDS with experience transforming systems, processes, and configuration from single to multi-product and multi-geographical site
• Preferred: Clear written communication aligning documentation to Quality Policy/Manual using Document Control tools
• Preferred: Inspirational leadership style capable of guiding teams through complexity and ambiguity
• Preferred: Experience presenting to executive leadership and acting as a visible leader during audits
• Preferred: Excellent verbal and written communication to influence stakeholders across departments
• Preferred: Strong knowledge of pharmaceutical GxP standards and their impact on SOPs and controlled documents
• Preferred: Experience designing document control processes that integrate with GxP Training
• Preferred: Extensive experience as Business System Owner of Veeva QDS

Education

• BA/BS degree in a scientific/technical/engineering field

Additional Requirements

• 10+ years of experience in pharmaceutical or life sciences industry
• Veeva certification
• Hybrid role with on-site presence at least 3 days per week