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Senior Director, Quality Control
Job in
Bedford, Middlesex County, Massachusetts, 01730, USA
Listed on 2026-10-06
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-06
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Data Scientist
Job Description & How to Apply Below
Role:
Senior Director, Quality Control leading Stoke's global QC strategy from early clinical to commercialization.
- develop and oversee analytical control and stability strategies;
- manage lifecycle of analytical methods for oligonucleotide therapeutics;
- lead QC operations including GMP release, in-process, and stability testing;
- partner with CMC, QA, Regulatory, and external CMOs;
- support regulatory filings (IND, NDA, IMPD, MAA);
- drive continuous improvement and inspection readiness;
- mentor QC team.
- BS/BA, MS, or PhD in Analytical Sciences or related field;
- 15+ years in QC with significant leadership in late-stage development and commercial manufacturing;
- deep knowledge of GMP, ICH guidelines, data integrity, and analytical method validation;
- experience with global regulatory submissions.
- biologics/oligonucleotide modalities,
- haploinsufficiency CNS/eye indications,
- GMP/QMS expertise,
- regulatory interface,
- leadership in QC lifecycle management,
- global compliance,
- 20% travel.
Work Setup: hybrid in Bedford, MA, relocating to Waltham, MA by 2026.
Position Requirements
10+ Years
work experience
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