Quality R&D Operations Drug Substance Director
Core
Lead quality oversight for drug substance development activities in R&D operations, ensuring compliance with cGMP and regulatory expectations while managing teams and supplier oversight.
Role type
Director of Quality R&D Operations (Drug Substance)
Builds
Clinical materials for product development
Domain
Biopharmaceuticals / Drug Substance Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, regulatory inspection readiness, team leadership and coaching, change control and deviation management, CAPA management, risk assessment, supplier and contract manufacturing oversight, FDA/EMA/MHRA regulatory knowledge
Preferred skills
Advanced degree in chemistry or chemical engineering, drug substance development process expertise (fermentation, synthesis, biologics), clinical supply release and stability program support, data-driven decision making, matrix organization experience
Technologies
Robotics, digital solutions, artificial intelligence
Responsibilities
Lead quality oversight for drug substance development activities; Own inspection readiness and respond to regulatory questions; Manage a team of quality and compliance professionals; Drive quality systems and processes for R&D drug substance workstreams; Support supplier and contract manufacturing oversight, audits, and qualification; Partner with cross-functional teams to enable product development milestones
Seniority
Director, strategic leadership and team management
