QA Manager, Audits and Inspections
FUJIFILM Corporation
Manager/Senior Manager, Analytical Operations
Praxis
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $145,000 - $175,000 per year
Job Level
Senior
About the role
- Collaborate with and support stakeholders within Analytical Development, Regulatory CMC, and Quality Assurance to ensure alignment on stability strategies and compliance with ICH guidelines.
- Ensure that analytical documentation (protocols, reports, change controls, etc.) are added contemporaneously to Praxis’ document management system.
- Contribute to regulatory filings (e.g., IND, IMPD, NDA) by preparing stability summaries and providing supporting information.
- Collaborate with other functions of Praxis CMC to execute the technical and business practices of the team.
- Lead the establishment, execution, and management of stability studies internally and at CDMO partners for drug substance and drug products across all development phases.
- Monitor CDMO performance with respect to agreed timelines for providing stability protocols and reports and establish metrics as needed.
- Review raw data, calculations, stability protocols, and stability summary reports in direct support of the Analytical Development Project Leads.
- Perform trend analysis of stability data to be used in shelf-life assessment.
- Ensure timely data review to support OOT/OOS investigations and implementation of corrective actions related to stability studies.
- Monitor execution of reference standard lifecycle management, including qualification, requalification, inventory, and expiry tracking in coordination with external testing sites.
Requirements
- Bachelor’s degree in Analytical Chemistry or a related discipline with at least 7 years of relevant industry experience in a GMP-regulated environment; advanced degree a plus but not required.
- Hands-on experience supporting stability and reference standard programs for small molecule drug substances and oral drug products (e.g., tablets, capsules, suspensions), including sample tracking, data trending, and documentation.
- Strong, working knowledge of stability study tracking software, such as Smartsheet, to monitor stability studies and evaluate CDMO performance.
- Working knowledge of US and EU cGMP requirements, ICH guidelines and compendial standards (e.g., USP, EP) applicable to stability studies and reference standards.
- Demonstrated success in building and maintaining productive partnerships with CDMO partners and associated service providers.
- Strong communication skills and the ability to work effectively with cross-functional teams including Analytical Development, Quality Assurance, and Regulatory Affairs.
- Ability to support investigations and trending activities, including compilation of stability data tables, graphs, and summaries for internal and regulatory use.
- Strong attention to detail along with the ability to perform meticulous data review and data transcription review.
- Demonstrates a high level of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit; can thrive in an agile environment.
- Physical and mental requirements include regular use of a computer, devices or other office equipment, clear communication, and occasional movement.
