Senior Manager/Associate Director, QA Investigations and Quality Projects

Corcept Therapeutics; Redwood City (CA); On-site; USD 173,000 - 227,000; Full time

Job summary

Corcept Therapeutics, based in Redwood City, CA, seeks a Senior Manager/Associate Director of QA Investigations and Quality Projects. You will lead quality investigations, manage deviations and CAPA activities, and drive cross‑functional quality initiatives to timely, compliant completion.

You will partner with Operations, Manufacturing, Supply Chain, QC, Regulatory Affairs, and external partners to ensure rigorous investigations, effective root-cause analysis, and sustainable corrective

Qualifications

• 7+ years in Quality Assurance or GMP-regulated roles.
• Experience leading deviation investigations and CAPA management.
• Strong knowledge of cGMP, FDA expectations, ICH guidance.
• Experience with cross-functional project leadership and risk assessment.
• Ability to interpret batch records, procedures, and validation docs.

Responsibilities

• Lead, author, review, and approve investigations related to deviations/nonconformances, complaints, temperature excursions, audit findings, and other quality events.
• Perform root cause analysis using 5 Whys, Fishbone, Fault Tree Analysis, risk assessment, and process mapping.
• Develop and manage CAPA plans with owners, timelines, effectiveness checks, and measurable outcomes.
• Serve as project manager for quality initiatives, remediation, inspection readiness, and cross-functional compliance projects.
• Coordinate cross-functional investigation teams with input from SMEs, aligned with GMP expectations.
• Track investigation, CAPA, and project milestones to ensure timely closure and risk escalation.
• Evaluate product quality impact and support disposition decisions by assessing risk to patient safety and regulatory compliance.
• Prepare investigation summaries, executive updates, trend reports, metrics, and presentations for management and audits.
• Identify recurring quality issues and recommend process improvements, training actions, or system enhancements.
• Partner with internal and external stakeholders to ensure investigation records and CAPA deliverables are inspection-ready.

Skills

Tech writing

Risk assessment

Project management

Cross-functional influence

Communication

Detail oriented

Education

Bachelor's degree in life sciences / related

Advanced degree preferred

Certifications (Six Sigma / ASQ CQE / CQA)

Tools

Electronic QMS

Microsoft Office

Project tracking tools

Quality metrics reporting

Job description

For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.

Our commercial portfolio includes treatments for hypercortisolism and oncology, and 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 the power of cortisol modulation to help address some of the most devastating diseases patients face today.

Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com.

The Senior Manager/Associate Director, QA Investigations and Quality Projects is responsible for leading complex quality investigations, managing deviations and CAPA activities, and driving cross-functional quality projects to timely and compliant completion. This role serves as a key Quality Assurance partner to Operations, Manufacturing, Supply Chain, Quality Control, Regulatory Affairs, and external partners to ensure investigation quality, regulatory compliance, effective root cause analysis, and sustainable corrective and preventive actions.

Responsibilities:

• Lead, author, review, and approve quality investigations related to deviations/nonconformances, complaints, temperature excursions, audit findings, and other quality events
• Perform structured root cause analysis using appropriate tools such as 5 Whys, Fishbone, Fault Tree Analysis, risk assessment, and process mapping
• Develop and manage CAPA plans that address root cause, reduce recurrence, and include clear owners, timelines, effectiveness checks, and measurable outcomes
• Serve as project manager for quality initiatives, process improvements, remediation activities, inspection readiness efforts, and cross-functional compliance projects
• Coordinate cross-functional investigation teams, ensuring input from subject matter experts is documented, scientifically sound, and aligned with GMP expectations
• Track investigation, CAPA, and project milestones to ensure timely closure, escalation of risks, and transparent communication to Quality and business leadership
• Evaluate product quality impact and support disposition decisions by assessing risk to patient safety, product quality, regulatory compliance, and supply continuity
• Prepare investigation summaries, executive updates, trend reports, metrics, and presentations for management review, client meetings, audits, and regulatory inspections
• Identify recurring quality issues and recommend process improvements, procedural updates, training actions, or system enhancements to improve quality performance
• Partner with internal and external stakeholders to ensure investigation records, CAPA documentation, and quality project deliverables are accurate, complete, and inspection-ready

Preferred Skills, Qualifications and Technical Proficiencies:

• Strong technical writing and investigation documentation skills
• Sound judgment in quality risk assessment and compliance decision-making
• Excellent project management, prioritization, and follow-through
• Ability to influence cross-functional teams without direct authority
• Strong communication skills with the ability to present complex issues clearly to leadership and external stakeholders
• High attention to detail, ownership, accountability, and continuous improvement mindset

Preferred Education and Experience:

• Bachelor’s degree in life sciences, pharmacy, chemistry, engineering, or a related scientific discipline; advanced degree preferred
• Minimum of 7 years of experience in Quality Assurance, Quality Systems, Manufacturing Quality, or related GMP-regulated functions within the pharmaceutical, biotechnology, medical device, or CDMO environment
• At least 5 years of experience leading deviation investigations, CAPA management, root cause analysis, quality risk assessments, and quality event closure
• Strong knowledge of cGMP regulations, FDA expectations, ICH guidance, quality systems, data integrity principles, and inspection readiness practices
• Experience managing cross-functional projects, timelines, deliverables, stakeholder alignment, and escalation of risks or delays
• Proficiency with electronic quality management systems, Microsoft Office applications, project tracking tools, and quality metrics reporting
• Experience supporting regulatory inspections, client audits, internal audits, or inspection response activities
• Certification or formal training in project management, quality auditing, Six Sigma, Lean, ASQ CQE, ASQ CQA, or root cause analysis methodologies
• Experience working with external manufacturing, packaging, laboratory, distribution, or service providers
• Ability to interpret technical data, batch records, procedures, validation documentation, laboratory records, and quality system records

The pay range that the Company reasonably expects to pay for this headquarters-based position is $173,430 - $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.

For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.

Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.

** Please visit our website at: https://www.corcept.com/**

Corcept is an Equal Opportunity Employer

Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.