Senior Manager/Associate Director, Product Complaints and Investigations

The role

This person will lead complex quality investigations, manage deviations and CAPA activities, and drive cross-functional quality projects. They will serve as a Quality Assurance partner to various departments to ensure regulatory compliance and effective root cause analysis.

What you will do

• Lead, author, review, and approve quality investigations related to deviations, complaints, and other quality events
• Perform structured root cause analysis using tools such as 5 Whys, Fishbone, and Fault Tree Analysis
• Develop and manage CAPA plans
• Serve as project manager for quality initiatives, process improvements, and inspection readiness efforts
• Coordinate cross-functional investigation teams
• Track investigation, CAPA, and project milestones
• Evaluate product quality impact and support disposition decisions
• Prepare investigation summaries, executive updates, trend reports, and presentations
• Identify recurring quality issues and recommend process improvements
• Partner with internal and external stakeholders to ensure inspection-ready documentation

Required qualifications

• Bachelor’s degree in life sciences, pharmacy, chemistry, engineering, or a related scientific discipline
• 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 envi
• 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
• Ability to interpret technical data, batch records, procedures, validation documentation, laboratory records, and quality system records

Nice to have

• Advanced degree
• 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
• High attention to detail, ownership, accountability, and continuous improvement mindset
• 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

Before you apply

• Applicants must be currently authorized to work in the United States on a full-time basis

About the company

Corcept is headquartered in Redwood City, California and focuses on the science of cortisol. The company has a commercial portfolio including treatments for hypercortisolism and oncology.