Associate Director, Quality Control
Core
Strategic Quality Control leadership for assigned biologics programs across the product lifecycle, serving as the primary QC representative and partner with internal and external stakeholders.
Role type
Associate Director, Quality Control (Biologics)
Builds
Biologic drug substance, drug product, intermediates, and relevant materials
Domain
Biopharmaceuticals / Biologics
Required skills
Biologics characterization and testing, Analytical method validation and transfer, Control strategy development, GMP compliance, Regulatory inspection readiness, Cross-functional stakeholder management, Team leadership and coaching, Risk assessment, CMC regulatory content authoring, Laboratory governance (internal/external)
Preferred skills
Advanced science degree (MS, MD, PharmD, PhD), Experience with CMOs/CDMOs and contract testing labs, Late-stage clinical program support, Strategic thinking, Executive communication
Technologies
HPLC, Mass Spectrometry, Microbiology, Stability testing equipment, LIMS (implied via analytical lifecycle management)
Responsibilities
Establish phase-appropriate QC and analytical strategies, Own or provide senior oversight of specifications and analytical methods, Provide QC oversight for testing at internal and external laboratories, Lead cross-program initiatives to strengthen QC governance, Lead, coach, and develop QC professionals, Support departmental strategy and budget management
Seniority
Senior, hands-on IC with leadership responsibilities