Director, Product Quality Small Molecule
Core
Lead product quality strategy, risk assessment, and regulatory compliance for small molecule drug development and manufacturing.
Role type
Director, Product Quality (Small Molecule)
Builds
Drug substance and drug product specifications, control strategies, and regulatory filings for life-saving therapies.
Domain
Biopharmaceuticals / Small Molecule Drug Development
Required skills
Product quality strategy, risk-based evaluation, regulatory filing authoring, technology transfer leadership, cross-functional alignment, inspection readiness, deviation management, stability strategy development, comparability approaches, analytical method validation.
Preferred skills
None stated.
Technologies
None stated.
Responsibilities
Lead Product Quality Team activities to align strategy across the product lifecycle; drive identification and mitigation of product quality risks via risk register; monitor cross-functional data to identify trends and ensure compliance; lead development of control strategies including IPCs and specifications; author and approve regulatory filings; assess product quality impact for changes and deviations; support technology transfer and new product launches; ensure inspection readiness (PAI/PLI); act as delegate to Senior Director as needed.
Seniority
Director, strategic leadership with hands-on technical execution.
