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Corcept Therapeutics · 3 months ago

Associate Director, Document Control

Redwood City, California, United States

Full-time

Hybrid

Lead/Staff, Director/Executive

$186K/yr - $219K/yr

10+ years exp

Corcept Therapeutics is a leader in the research and development of cortisol modulators aimed at treating serious diseases. They are seeking an Associate Director to lead the Document Control Program, ensuring compliance with GxP requirements and enhancing the quality management system.

BiotechnologyMedicalPharmaceutical

Comp. & Benefits

No H1B

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

Qualification

Document ControlGxP ComplianceVeeva QDSOrganizational Change ManagementPharmaceutical ExperienceSOP DevelopmentTechnical CommunicationLeadershipCollaboration

Required

Proven track record of advancing document control by remediating critical gaps, and implementing sustainable, risk-based controls that achieve GxP requirements

Experience in pharmaceutical or biotechnology involving single product to multi-product transformation including the design of scalable business processes, modification of computer systems, and updating metadata

Strong leadership skills to deliver high-visibility changes, drive implementation with resilience and clarity, and resolve obstacles and dynamic priorities

Ability to communicate a clear and compelling vision, and guide teams through change using collaborative 'come with me' leadership

Experience leading and mentoring a team of Document Control professionals

Ability to strengthen the Document Control Program and supporting software by remediating compliance risks, and architecting processes, metadata, and complex computer system configurations including security

Experience evaluating and implementing solutions to support a scalable, multi-product environment in compressed timelines resulting in a robust, inspection-ready program that achieves GxP standards

Experience partnering closely with Training program lead to integrate document process changes and system configuration changes

Assume software Business System Owner responsibilities, ensuring data and metadata maintenance and periodic system review

Experience driving and managing high-volume SOP authorship, revision, and implementation under accelerated timelines

Ability to establish and track key performance indicators (KPIs) to monitor and ensure system effectiveness, inspection readiness, and accountability

Preferred

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 configuration from a single product to a multi-product and multi-geographical site system

Clear and concise written communication skills to align documentation to Corcept's Quality Policy/Manual, using established Document Control tools to deliver consistent, quality written work

Inspirational leadership style with a proven ability to guide teams through complexity and ambiguity

Experienced in presenting to executive leadership and acting as a visible leader during audits and inspections

Excellent verbal and written communication skills with the ability to influence a wide range of stakeholders in various departments

Strong working knowledge of pharmaceutical GxP standards and their impact on SOPs, work instructions, and controlled documents

Designed applicable document control processes that integrate with GxP Training program

Extensive experience as Business System Owner of Veeva QDS