Director, Quality Control

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 out-of-trend and out-of-specification results are addressed promptly
- Provide stability study progress summaries and ensure stability reports are completed promptly
- Oversee internal documentation to support retest periods and shelf-life extension based on ongoing stability data
- 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 methods, 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, expanding QC oversight over time

Preferred Skills/Qualifications/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 managing analytical testing in an outsourced environment
- Experience using statistical tools for data trend analysis and projection of retest period or shelf-life
- Excellent communication and collaboration skills

Preferred Education and Experience:
- S. in a relevant scientific discipline; advanced degree in Analytical Chemistry or related disciplines
- 10+ years QC experience in the pharmaceutical industry

Application Instructions/Requirements:
- Applicants must be authorized to work in the United States on a full-time basis.