Lead Quality Assurance for RTR242, providing end-to-end oversight of manufacturing and QC activities at CDMOs, including tech transfer, performance monitoring, deviation oversight, issue resolution, and continuous improvement and data integrity.

Define and maintain a scientifically sound, risk-based, phase-appropriate control strategy across materials, manufacturing processes, analytical methods, and specifications to ensure product identity, strength, quality, purity, and stability in alignment with cGMP expectations.

As part of the control strategy, define, justify, and maintain drug substance and drug product specifications, including critical quality attributes, acceptance criteria, scientific rationale, and lifecycle management.

Lead the analytical method strategy across the product lifecycle, including QC release and stability methods supporting clinical development.

Oversee analytical method development, qualification, and validation at CDMOs and CROs in alignment with ICH guidance and phase-appropriate regulatory expectations.

Establish and oversee stability strategies, including protocol design, stability-indicating methods, data trending and interpretation, and shelf-life proposals.

Serve as the product quality subject-matter expert for investigations, deviations, and CAPAs, ensuring robust root cause analysis and effective resolution.

Identify and mitigate analytical, quality, and control strategy gaps and risks to support CMC readiness, compliant product release, and regulatory submissions.

Serve as the primary analytical and product quality interface with CDMOs and CROs, establishing clear responsibilities, robust quality agreements, and governance to support effective oversight and sustained inspection readiness.

Partner cross-functionally with Research, CMC, Regulatory Affairs, and QMS stakeholders to ensure analytical and quality strategies are scientifically sound, compliant, and clearly and defensibly documented.

Contribute to global regulatory submissions and support health authority interactions in collaboration with Regulatory Affairs.