Senior Manager/Associate Director, Quality Control

Scorpion Therapeutics; Boston (MA); Hybrid; USD 150,000 - 190,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Manager/Associate Director of Quality Control to oversee analytical testing for clinical and commercial drug substances and products, ensuring compliance with ICH and cGMP standards.

In this role you will lead stability assessments, coordinate with external labs/CMOs, and support regulatory submissions. You may travel up to 20% and participate in international audits while guiding a QC team.

Qualifications

• 5+ years in pharmaceutical QC at Senior Manager level or 8+ years at Associate Director level
• Strong knowledge of ICH guidelines, cGMP, and global regulatory standards
• Experience coordinating with external labs, audits, and cross-functional teams
• Excellent written and verbal communication skills in regulatory contexts

Responsibilities

• Oversee analytical testing for clinical and commercial drug substances and products
• Lead stability assessments and trending
• Coordinate with external labs and CMOs
• Support regulatory submissions (IND, NDA, CTA) QC documentation
• Facilitate tech transfers and compliance audits
• Lead or supervise QC team as applicable
• Ensure adherence to quality policies and participate in international audits and travel

Skills

Stability management

QC testing

Regulatory documentation

ICH guidelines

cGMP

External labs & audits

Cross-functional collaboration

Excellent communication

Education

BS/MS in Chemistry/Pharma/QA

Tools

HPLC/UPLC methods

Analytical method validation

Job description

Role

Senior Manager/Associate Director of Quality Control overseeing analytical testing for clinical and commercial drug substances and products, ensuring compliance with ICH and cGMP standards.

Responsibilities

• manage testing results, stability programs, reference standards, specifications, investigations, and QC oversight across manufacturing stages


• lead stability assessments and trending


• coordinate with external labs and CMOs


• support regulatory submissions (IND, NDA, CTA) QC documentation


• facilitate tech transfers and compliance audits


• lead or supervise QC team if applicable


• ensure adherence to quality policies, and may participate in international audits and travel

Requirements

• 5+ years (Senior Manager) or 8+ years (Associate Director) experience in pharmaceutical QC, preferably within small molecules or biologics, with proven expertise in stability management, QC testing, investigations, and regulatory documentation


• strong knowledge of ICH guidelines, cGMP, and global regulatory standards


• experience with external labs, audits, and cross-functional collaboration


• excellent communication skills

High Value

small molecule/biologics, clinical and commercial stages, IND/NDA submissions, stability and specifications management, cGMP, international regulatory environment.

Work Setup

hybrid or onsite Vancouver, BC or Boston, MA; up to 20% travel.