Associate Director, Quality Systems Technology

Role Summary

Associate Director, Quality Systems Technology leads the Quality Systems Technology (QST) program, with primary responsibility for evaluating Veeva Quality software projects and prioritizing the most critical initiatives for the QA department and Corcept. The role requires a strategic, cross-functional leader who can justify software priorities, set direction, and manage complex system projects, including supporting validation tasks and direct project execution oversight. The role translates business growth and rising complexity into a coherent software strategy, including a two-year framework to sustain growth and organizational maturity, and supports all phases of clinical, manufacturing, and development operations with risk-based, phase-appropriate solutions. This is a hybrid role with on-site presence typically three days per week.

Responsibilities

• Align QST objectives with departmental and corporate expansion growth goals, ensuring projects deliver measurable business value
• Partner cross-functionally to deliver phase-appropriate solutions that strengthen Corcept’s quality management system and meet business needs
• Evaluate, prioritize and deliver scalable software solutions that support GxP-compliant operations, ongoing enhancements, and day-to-day activities
• Exercise sound judgment in balancing GMP and GCP considerations to meet regulatory and operational requirements
• Balance competing priorities and compliance risks while maintaining project momentum
• Serve as Subject Matter Expert (SME) for Veeva Quality in regulatory inspections by proactively identifying compliance risks and implementing corrective actions or mitigations
• Lead, coach, and develop the Quality Systems team by setting goals and supporting development and growth
• Partner with teams to manage vendor relationships, agreements, and user licenses to scale with Corcept’s evolving software needs

Qualifications

• Required: Demonstrated ability to navigate ambiguity and set direction
• Required: Proven leadership skills in a cross-functional role
• Required: Guide and develop team members
• Required: Excellent problem-solving and meeting facilitation skills
• Required: Excellent written and oral communication skills
• Required: Working knowledge of Veeva Quality, LMS systems
• Required: Ability to influence others at various levels of the organization
• Preferred: Previous hands-on configuration experience is a plus
• Required: Direct involvement and experience with regulatory inspections and audits
• Required: Vendor evaluation and selection process
• Required: Working knowledge of principles for software validation, CSA, GAMP5
• Required: Experienced and well-versed in System Development Lifecycle (SDLC)
• Preferred: 10+ years’ experience in pharmaceutical QA
• Preferred: Strong knowledge of GCP and GMP requirements, including ICH E6, ICH Q9-Q10, 21 CFR 210/211, and specific regulatory authority requirements (FDA, EMA, PMDA, etc.)
• Preferred: Experience working with enterprise systems, integrations, and phase-appropriate QMS implementation
• Preferred: Experience with managing budgets

Education

• BA/BS in a scientific discipline