Director, Product Quality Small Molecule
Core
Lead Product Quality Team activities to align product quality strategy, priorities, and deliverables across the product lifecycle for small molecule therapies.
Role type
Director, Product Quality (Small Molecule)
Builds
Drug substance and drug product specifications, stability strategies, and regulatory filings for patient-oriented therapies.
Domain
Biopharmaceuticals / Small Molecule Drug Development
Required skills
Risk-based quality evaluation, regulatory filing strategy, technology transfer leadership, cross-functional alignment, inspection readiness, control strategy development, deviation/event assessment
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead the development of control strategies including in-process controls and stability strategies; Author and approve regulatory filings associated with product quality; Monitor cross-functional process and product data to identify trends and ensure compliance risks are addressed; Act as delegate to Senior Director, Product Quality Heads as needed
Seniority
Director, strategic leadership & cross-functional alignment
