- Provide scientific leadership for QC GMP activities, including method transfer, qualification, validation, and lifecycle management for drug substance and drug product.
- Serve as a QC subject-matter expert supporting release and stability testing, including data review, trending, and interpretation.
- Lead or support investigations of deviations, OOS, and OOT results, including root cause analysis and development of corrective and preventive actions (CAPAs).
- Collaborate closely with Analytical Development and CMC teams to ensure successful method transfers to QC laboratories and external CMOs.
- Provide oversight of QC activities conducted at contract testing laboratories and manufacturing partners, including review of data packages and ensuring compliance with quality and regulatory requirements.
- Contribute to the development and execution of control strategies for small-molecule drug substance and drug product.
- Author, review, and approve QC-related documents, including methods, specifications, protocols, validation reports, and regulatory submission content.
- Support regulatory inspections and audits, including preparation, response, and follow-up activities.
- Identify opportunities for continuous improvement in QC processes, technologies, and compliance practices.
- Mentor junior staff and serve as a technical resource across functional teams.