Director, Quality Control
Corcept Therapeutics•Redwood City, CA
•Onsite
About The Position
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.
Requirements
- Applicants must be currently authorized to work in the United States on a full-time basis.
Nice To Haves
- 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
- S. in relevant scientific discipline.
- Advanced degree in Analytical Chemistry or other relevant disciplines
- 10+ years 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 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
Benefits
- The pay range that the Company reasonably expects to pay for this headquarters-based position is $215,300-$253,200
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What This Job Offers
Job Type
Full-time
Career Level
Director
