Director - Quality Control

2d2 days ago

Corcept Therapeutics

Redwood City, US · Full-time · $215,300 – $253,200

About this role

This position provides strategic and organizational leadership for the Quality Control function, supporting both development and commercial programs. The role has end-to-end oversight of all stability programs at contract laboratories and authors the stability sections of regulatory filings.

Daily responsibilities include overseeing stability studies conducted at external laboratories, ensuring compliance, data integrity, and timely execution. The director reviews and trends stability data, alerting project teams of adverse trending, and collaborates with vendors to address out-of-trend or out-of-specification results promptly.

This role partners closely with the Senior Director of Analytical Development and Quality Control to continuously strengthen, expand, and scale the QC function. The director works with internal cross-functional teams to provide stability progress summaries and ensure timely completion of stability reports.

The position is expected to progressively expand scope into broader QC oversight, building capabilities, infrastructure, and processes to support the company's growth. As Corcept advances clinical trials in hypercortisolism, solid tumors, ALS, and liver disease, the director will play a key role in unlocking the power of cortisol modulation.

Corcept has been singularly focused on the science of cortisol for over 25 years, discovering more than 1,000 proprietary selective cortisol modulators. The company's commercial portfolio includes treatments for hypercortisolism and oncology, with advanced clinical trials in several devastating diseases.

Requirements

Strong technical expertise in stability study design, execution, and interpretation
Proven experience managing stability programs supporting late-stage development and global regulatory submissions
Experience in managing analytical testing in an outsourced environment
Experience in using statistical tools for data trend analysis and projection of drug substance retest period or drug product shelf-life
Excellent communication and collaboration skills with proven ability to work effectively with other functional groups
B.S. in a relevant scientific discipline; advanced degree in Analytical Chemistry or other relevant disciplines preferred
10+ years of QC experience in the pharmaceutical industry

Responsibilities

Lead the QC function with primary responsibility for the design, execution, and oversight of stability programs
Oversee stability studies conducted at external laboratories, ensuring compliance, data integrity, and timely execution
Review, trend, and maintain stability data; alert project teams of any adverse trending
Collaborate with vendors and internal cross-functional teams to ensure out-of-trend and out-of-specification results are addressed promptly
Provide stability study progress summaries to project teams and ensure stability reports are completed promptly
Oversee internal documentation to support retest periods and shelf-life extension based on data from ongoing stability studies
Support analytical project leads in preparation of batch analysis and author/review stability sections for regulatory submissions
Partner with the Sr Director of ADQC to build and enhance QC capabilities, infrastructure, and processes, with expectation to progressively expand scope into broader QC oversight