Director, Quality Control

Director, Quality Control Corcept Therapeutics - 2.4 Redwood City, CA Job Details $215,300 - $253,200 a year 1 day ago Qualifications Project reporting Data integrity assurance Research design Statistics Stability testing Management Analytical chemistry Stability studies in drug product development Team leadership Technical documentation Quality control statistical data analysis Trend analysis Data summary reports Quality reports Data integrity and documentation Analysis skills Laboratory reports Bachelor's degree Pharmaceutical company experience Compliance documentation Quality compliance management Chemistry Regulatory submission editing and review Verification of laboratory test methods Quality control within pharmaceutical industry Quality control communication Senior level Cross-functional collaboration Test validation method Project leadership Full 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 position will provide strategic and organizational leadership for the Quality Control function supporting Corcept's development and commercial programs. This position will have end-to-end oversight of all stability programs at contract laboratories and will author the stability sections of regulatory filings. This position will partner closely with the Sr Director of Analytical Development & Quality Control (ADQC) to continuously strengthen, expand, and scale the QC function, with increasing responsibility across broader QC activities.

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 the project team of any adverse trending Collaborate with vendors and internal cross-functional teams to ensure that out-of-trend and out-of-specification results are addressed promptly Provide stability study progress summaries to project teams and ensure that stability reports are completed promptly Oversee internal documentation to support retest periods and shelf-life extension based on data generated from ongoing stability studies Support analytical project leads in preparation of batch analysis; author and review stability sections required for regulatory submissions Support analytical project leads in reviewing method validation protocols, reports, analytical method and test data Manage data review qualifications of contract laboratories Partner with the Sr Director of ADQC to build and enhance QC capabilities, infrastructure, and processes, with the expectation to progressively expand scope into broader QC oversight

Preferred Skills, Qualifications or Technical Proficiencies:

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

Preferred Education and Experience:

S. in relevant scientific discipline. Advanced degree in Analytical Chemistry or other relevant disciplines 10+ years QC experience in the pharmaceutical industry The pay range that the Company reasonably expects to pay for this headquarters-based position is $215,300-$253,200; 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.