Director, Product Quality Lead
Core
End-to-end Quality leadership for designated biopharmaceutical products from pre-clinical through commercial filing and approval.
Role type
Director, Product Quality Lead (CMC)
Builds
Drug substance, drug product, and process validation for cardiovascular disease treatments
Domain
Biopharmaceuticals / Cardiovascular therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC program leadership, GMP compliance, risk-based decision making, regulatory filing support, technology transfer, process validation, stability program development, CDMO quality oversight, change control management, deviation and investigation handling
Preferred skills
Small molecule development, combination product experience, advanced degree in life sciences
Technologies
IND, IMPD, NDA, MAA, Module 3 submissions
Responsibilities
Develop and drive product quality strategy aligned with commercial goals; Serve as Quality representative on CMC program teams; Provide Quality oversight of development and manufacturing activities; Orchestrate end-to-end control strategy development; Lead product-specific risk assessments; Oversee execution of key Quality processes including change controls and investigations; Provide Quality leadership for technology transfer and process validation; Provide Quality oversight of CDMOs through governance mechanisms; Act as Quality lead for CMC regulatory filings and agency responses; Lead inspection readiness activities
Seniority
Director, strategic leadership with hands-on execution
