Associate Director, Quality Systems Technology
Scorpion Therapeutics, Redwood City, CA, United States
Overview
For more than 25 years, Corcept has been focused on the science of cortisol, a hormone that when unregulated can play a role in a broad range of diseases.
Our commercial portfolio includes treatments for hypercortisolism and oncology. The company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking cortisol modulation to help address serious diseases patients face today.
Corcept is headquartered in Redwood City, California. To learn more, visit the Corcept website (no external links included here).
Role The Corcept Quality Systems Technology (QST) leader will have primary responsibility for evaluating Veeva Quality software projects and prioritizing the most critical projects for the QA department and Corcept. This role requires a strategic thinker who partners cross-functionally to achieve shared objectives, prioritizes and justifies software projects to meet objectives, and sets clear direction to get there. The leader should be comfortable leading complex system projects, supporting validation tasks as needed, and directly managing project execution while maintaining strategic oversight.
The leader should demonstrate the ability to translate business growth and rising complexity into a coherent software strategy, including a 2-year strategic framework that supports sustained growth and organizational maturity. Projects include new implementations, software enhancements, and other continual process improvements.
The role will support all of Corcept’s quality and GxP operations, leading cross-functional collaboration across teams with diverse and opposing priorities and aligning on the best path forward to achieve high-impact outcomes. Because QST supports all phases of clinical, manufacturing, and development operations, this individual will need to apply sound judgment in developing practical, risk-based, and phase-appropriate solutions.
This is a hybrid role that typically requires on-site presence 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 successfully deliver scalable software solutions that support GxP-compliant operations, ongoing enhancements, and day-to-day operations
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, implementing corrective actions or mitigations
Lead, coach, and develop the Quality Systems team by setting goals, identifying development opportunities, and assisting in individual career development and growth
Partner with teams to manage vendor relationships, agreements, and user licenses to scale with Corcept’s expanding footprint and evolving software needs
Required Skills, Qualifications, and Technical Proficiencies
Demonstrated ability to navigate ambiguity and set direction
Proven leadership skills in an across-functional role
Guide and develop team members
Excellent problem-solving and meeting facilitation skills
Excellent written and oral communication skills
Working knowledge of Veeva Quality and LMS systems
Ability to influence others at various levels of the organization
Hands-on configuration experience is a plus
Direct involvement and experience with regulatory inspections and audits
Vendor evaluation and selection process
Working knowledge of software validation principles, CSA, GAMP5
Experienced and well-versed in System Development Lifecycle (SDLC)
Preferred Education and Experience
BA/BS in a scientific discipline
10+ years’ experience in pharmaceutical QA
Strong knowledge of GCP and GMP requirements, including ICH E6, ICH Q9-Q10, 21 CFR 210/211, and regulatory authority requirements (FDA, EMA, PMDA, etc.)
Experience working with enterprise systems, integrations, and phase-appropriate QMS implementation
Experience with managing budgets
The pay range that the Company reasonably expects to pay for this headquarters-based position is $192,700 – $226,700; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
Privacy and Compliance For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information, please refer to our Privacy Notice. Corcept is an Equal Opportunity Employer.
Please visit our website at: Corcept.com
Note: Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. We use third-party tools to help with advertising our jobs; please ensure communications are from Corcept.
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Our commercial portfolio includes treatments for hypercortisolism and oncology. The company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking cortisol modulation to help address serious diseases patients face today.
Corcept is headquartered in Redwood City, California. To learn more, visit the Corcept website (no external links included here).
Role The Corcept Quality Systems Technology (QST) leader will have primary responsibility for evaluating Veeva Quality software projects and prioritizing the most critical projects for the QA department and Corcept. This role requires a strategic thinker who partners cross-functionally to achieve shared objectives, prioritizes and justifies software projects to meet objectives, and sets clear direction to get there. The leader should be comfortable leading complex system projects, supporting validation tasks as needed, and directly managing project execution while maintaining strategic oversight.
The leader should demonstrate the ability to translate business growth and rising complexity into a coherent software strategy, including a 2-year strategic framework that supports sustained growth and organizational maturity. Projects include new implementations, software enhancements, and other continual process improvements.
The role will support all of Corcept’s quality and GxP operations, leading cross-functional collaboration across teams with diverse and opposing priorities and aligning on the best path forward to achieve high-impact outcomes. Because QST supports all phases of clinical, manufacturing, and development operations, this individual will need to apply sound judgment in developing practical, risk-based, and phase-appropriate solutions.
This is a hybrid role that typically requires on-site presence 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 successfully deliver scalable software solutions that support GxP-compliant operations, ongoing enhancements, and day-to-day operations
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, implementing corrective actions or mitigations
Lead, coach, and develop the Quality Systems team by setting goals, identifying development opportunities, and assisting in individual career development and growth
Partner with teams to manage vendor relationships, agreements, and user licenses to scale with Corcept’s expanding footprint and evolving software needs
Required Skills, Qualifications, and Technical Proficiencies
Demonstrated ability to navigate ambiguity and set direction
Proven leadership skills in an across-functional role
Guide and develop team members
Excellent problem-solving and meeting facilitation skills
Excellent written and oral communication skills
Working knowledge of Veeva Quality and LMS systems
Ability to influence others at various levels of the organization
Hands-on configuration experience is a plus
Direct involvement and experience with regulatory inspections and audits
Vendor evaluation and selection process
Working knowledge of software validation principles, CSA, GAMP5
Experienced and well-versed in System Development Lifecycle (SDLC)
Preferred Education and Experience
BA/BS in a scientific discipline
10+ years’ experience in pharmaceutical QA
Strong knowledge of GCP and GMP requirements, including ICH E6, ICH Q9-Q10, 21 CFR 210/211, and regulatory authority requirements (FDA, EMA, PMDA, etc.)
Experience working with enterprise systems, integrations, and phase-appropriate QMS implementation
Experience with managing budgets
The pay range that the Company reasonably expects to pay for this headquarters-based position is $192,700 – $226,700; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
Privacy and Compliance For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information, please refer to our Privacy Notice. Corcept is an Equal Opportunity Employer.
Please visit our website at: Corcept.com
Note: Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. We use third-party tools to help with advertising our jobs; please ensure communications are from Corcept.
#J-18808-Ljbffr