Senior Director, Quality Control
Core
Leads strategy and execution of Quality Control activities for clinical and commercial manufacturing, ensuring global GMP compliance and robust analytical support across external testing laboratories.
Role type
Senior Director, Quality Control (Pharmaceuticals/Biologics)
Builds
Clinical and commercial manufacturing pipelines for neuromuscular disease therapeutics
Domain
Biopharmaceuticals / Gene Therapy / Neuromuscular Diseases
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, analytical chemistry, regulatory submissions (CMC), contract laboratory management, stability program oversight, data integrity, change control, CAPA, OOS/OOT investigation, team leadership, stakeholder negotiation
Preferred skills
Advanced degree in chemistry/analytical chemistry, experience with antibodies and small molecules
Technologies
HPLC, GC, Mass Spectrometry, Bioburden testing, Endotoxin testing, Environmental monitoring systems
Responsibilities
Define and execute QC strategy aligned with business objectives; Ensure contract testing labs meet GMP and inspection readiness; Author/Review CMC sections for regulatory filings; Lead Specification and Stability Review Boards; Oversee analytical method transfers, qualifications, and validations; Manage out-of-specification and out-of-trend investigations; Recruit and mentor QC team members
Seniority
Senior Director, strategic leadership & functional management