Director, QC Product Readiness
Core
Leads the organization of QC Leads responsible for assigned commercial products, establishing direction, governance, and resource priorities for product readiness and analytical lifecycle activities.
Role type
Director, Quality Control Product Readiness
Builds
Commercial product supply and regulatory compliance for biopharmaceutical therapies
Domain
Biopharmaceuticals / Quality Control / Regulatory Affairs
Required skills
Pharmaceutical Quality Control leadership, Analytical method validation and transfer, cGMP principles, Data integrity, Global regulatory requirements, Cross-functional stakeholder influence, Portfolio prioritization, Technical decision frameworks
Preferred skills
None stated
Technologies
None stated
Responsibilities
Oversee clinical-to-commercial QC transitions and ongoing product readiness; Manage portfolio priorities, testing capacity, resources, and execution risks; Provide technical guidance for complex analytical issues and regulatory commitments; Build, lead, and develop a high-performing team of QC Leads; Define the QC Lead operating model and performance standards.
Seniority
Director, strategic leadership & team management