Senior Director, Quality Control

Scorpion Therapeutics; Bedford (MA); Hybrid; USD 190,000 - 270,000; Full time

Job summary

Scorpion Therapeutics in Bedford, MA is seeking a Senior Director, Quality Control to lead Stoke's global QC strategy from early clinical to commercialization. You will design analytical control and stability strategies and manage method lifecycle for oligonucleotide therapeutics.

You will partner with CMC, QA, Regulatory and CMOs, support IND/NDA filings, drive inspection readiness, and mentor the QC team. This role requires 15+ years in QC leadership and deep GMP/ICH expertise with 20% travel.

Qualifications

• 15+ years in QC with 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.

Responsibilities

• 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.

Skills

Analytical QC leadership

Regulatory submissions

GMP/ICH knowledge

Education

Analytical Sciences degree

Tools

GMP/QMS systems

Job description

Role: Senior Director, Quality Control leading Stoke's global QC strategy from early clinical to commercialization.

Responsibilities

• 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.

Requirements

• 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.

HighValue

• biologics/oligonucleotide modalities,
• haploinsufficiency CNS/eye indications,
• GMP/QMS expertise,
• regulatory interface,
• leadership in QC lifecycle management,
• global compliance,
• 20% travel.

WorkSetup: hybrid in Bedford, MA, relocating to Waltham, MA by 2026.