Director, Quality Control
Core
Leads global Quality Control activities, including oversight of external laboratories for analytical testing, release, and stability programs across clinical and commercial stages.
Role type
Director, Quality Control (Biopharma)
Builds
Supports clinical and commercial programs for neuromuscular disease therapeutics
Domain
Biopharmaceuticals / Analytical Chemistry / cGMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic vision for QC function, Organizational structure design, External laboratory management, Analytical method validation, Stability program management, OOS/OOT investigation leadership, Regulatory CMC content preparation, Cross-functional collaboration
Preferred skills
PhD in Chemistry/Analytical Chemistry, Oligonucleotide therapeutics experience, Mass spectrometry expertise, Bioanalytical assays experience
Technologies
SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA, Mass Spectrometry
Responsibilities
Define and execute strategic vision for QC function, Establish organizational structure and processes, Lead and develop QC personnel, Oversee external QC laboratories and performance metrics, Review and approve analytical method qualification and validation protocols, Author and approve stability protocols and reports, Prepare analytical CMC content for regulatory submissions, Participate in regulatory inspections
Seniority
Director, strategic leadership & operational oversight
