Principal Scientist, External Quality Analytical Oversight

Quality Control Leadership & Strategy

• Define, implement, and continuously improve the QC strategy for commercial small molecule programs in alignment with overall CMC and quality objectives.
• Serve as the point of contact for overall QC activities including method validation and transfer, reference materials, specifications, cGMP release testing, stability strategy and testing, and supervision of testing at external contract testing laboratories.
• Develop and maintain phase-appropriate QC strategies and processes to support manufacturing and regulatory submissions.
• Responsible for the management and approval of specifications, collaborating cross-functionally to establish scientifically sound and phase-appropriate specifications.
• Represent QC on cross-functional product development teams, providing technical input and direction for analytical and quality decisions.
• Identify and drive opportunities for improvement in QC testing, workflows, data management, and compliance processes.
• Proactively identify and escalate potential QC risks, and communicate QC activities, risks, and issues to relevant stakeholders.

Analytical Testing & Documentation

• Oversee and ensure compliant execution of QC testing for raw materials, intermediates, drug substance, and drug product.
• Ensure timely creation, review, and approval of QC documentation including test methods, protocols, reports, CoAs, and quality records.
• Provide QC oversight to contract testing laboratories, coordinating testing activities for on-time delivery and confirming compliance with cGMP and data integrity expectations.
• Direct and oversee timely resolution of QC testing related investigations with comprehensive root-cause analysis, risk assessment, and effective CAPAs.

Compliance & Regulatory Affairs

• Ensure QC operations comply with cGMP, FDA, EMA, ICH, and other applicable regulations.
• Drive excellence in data integrity, documentation practices, and traceability across QC activities.
• Serve as a QC subject matter expert to draft and review CMC sections and supporting documents for regulatory filings and response to questions (RTQs).

Cross-Functional Collaboration

• Partner closely with Analytical Development, Manufacturing, Quality Assurance, Regulatory, and Supply Chain to ensure seamless coordination of analytical strategy and QC testing support throughout the product lifecycle.
• Support technology transfer and method implementation at internal and external laboratories.
• Provide QC input into regulatory submission documentation.