Associate Director, Quality Systems Technology
Corcept Therapeutics
4 hours ago
Remote friendly (Redwood City, CA)
United States
$192,700 - $226,700 USD yearly
Operations
Hybrid (on-site 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 the quality management system and meet business needs
- Evaluate, prioritize, and deliver scalable Veeva Quality solutions supporting GxP-compliant operations, enhancements, and day-to-day operations
- Balance GMP and GCP considerations to meet regulatory and operational requirements
- Manage competing priorities and compliance risks while maintaining project momentum
- Serve as SME for Veeva Quality in regulatory inspections by proactively identifying compliance risks and implementing corrective actions/mitigations
- Lead, coach, and develop the Quality Systems team (set goals, identify development opportunities, support career growth)
- Manage vendor relationships, agreements, and user licenses to scale with evolving software needs
Required Skills/Qualifications:
- Ability to navigate ambiguity and set direction
- Proven cross-functional leadership; ability to guide and develop team members
- Strong problem-solving and meeting facilitation; excellent written and oral communication
- Working knowledge of Veeva Quality and LMS systems
- Ability to influence stakeholders at multiple org levels
- Direct experience with regulatory inspections and audits
- Vendor evaluation and selection
- Working knowledge of software validation principles (CSA, GAMP5)
- Experience with System Development Lifecycle (SDLC)
Preferred:
- BA/BS in a scientific discipline
- 10+ years pharmaceutical QA experience
- Strong GCP/GMP knowledge (ICH E6, ICH Q9-Q10, 21 CFR 210/211; FDA/EMA/PMDA, etc.)
- Experience with enterprise systems, integrations, phase-appropriate QMS implementation
- Budget management experience
Application instructions:
- Applicants must be currently authorized to work in the United States on a full-time basis.
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 the quality management system and meet business needs
- Evaluate, prioritize, and deliver scalable Veeva Quality solutions supporting GxP-compliant operations, enhancements, and day-to-day operations
- Balance GMP and GCP considerations to meet regulatory and operational requirements
- Manage competing priorities and compliance risks while maintaining project momentum
- Serve as SME for Veeva Quality in regulatory inspections by proactively identifying compliance risks and implementing corrective actions/mitigations
- Lead, coach, and develop the Quality Systems team (set goals, identify development opportunities, support career growth)
- Manage vendor relationships, agreements, and user licenses to scale with evolving software needs
Required Skills/Qualifications:
- Ability to navigate ambiguity and set direction
- Proven cross-functional leadership; ability to guide and develop team members
- Strong problem-solving and meeting facilitation; excellent written and oral communication
- Working knowledge of Veeva Quality and LMS systems
- Ability to influence stakeholders at multiple org levels
- Direct experience with regulatory inspections and audits
- Vendor evaluation and selection
- Working knowledge of software validation principles (CSA, GAMP5)
- Experience with System Development Lifecycle (SDLC)
Preferred:
- BA/BS in a scientific discipline
- 10+ years pharmaceutical QA experience
- Strong GCP/GMP knowledge (ICH E6, ICH Q9-Q10, 21 CFR 210/211; FDA/EMA/PMDA, etc.)
- Experience with enterprise systems, integrations, phase-appropriate QMS implementation
- Budget management experience
Application instructions:
- Applicants must be currently authorized to work in the United States on a full-time basis.