Senior QA Investigations & Quality Projects Lead

Corcept Therapeutics; Redwood City (CA); Sur place; USD 173 000 - 227 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Tech writing

Risk assessment

Project management

Cross-functional influence

Communication

Detail oriented

Formation

Bachelor's degree in life sciences / related

Advanced degree preferred

Certifications (Six Sigma / ASQ CQE / CQA)

Outils

Electronic QMS

Microsoft Office

Project tracking tools

Quality metrics reporting

Description du poste

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