Analytical Quality Assurance, Associate Director

Scorpion Therapeutics; Boston (MA); On-site; USD 157,000 - 235,000; Full time

Job summary

Scorpion Therapeutics in Boston seeks an Associate Director Quality Assurance to provide QA oversight for QC and analytical development across cell & gene programs, including release testing, deviations, and OOS investigations.

The role leads method validation/transfer, supports audits, CAPA, and leverages MES/LIMS/eQMS and digital analytics to ensure GMP compliance and continuous improvement.

Qualifications

• 8+ years in a regulated pharmaceutical environment.
• Experience with QA for QC in cell therapies.
• Ability to lead RCA and CAPA initiatives.

Responsibilities

• Provide QA oversight of QC and analytical development activities across Cell & Gene programs.
• Lead QA review/approval of analytical development, qualification/validation, and analytical transfer activities.
• Ensure stability programs follow established protocols and regulations; review regulatory submissions and assist with responses.
• Execute RCA and CAPA for OOS/OOT results and related investigations.
• Perform QA review/approval of QC documentation for deviations, OOS/OOT, and change control.
• Provide QA operational oversight for internal QC labs and external contract testing labs; draft/enforce Quality Agreements.
• Leverage MES/LIMS/eQMS and digital analytics for quality oversight.
• Act as SME during audits/inspections; support QA risk management and continuous improvement; develop quality metrics at contract organizations.

Skills

GxP QA/QC knowledge

Regulatory compliance

MES/LIMS/eQMS

Analytical method development

Project leadership

Education

Master’s degree in scientific field

PhD preferred

Tools

LIMS

MES

eQMS

Job description

General Summary

Associate Director (AD) Quality Assurance (QA for QC) provides quality oversight of Quality Control and analytical development activities for Cell & Gene programs, including release/stability testing and QA support for deviations and out-of-specification investigations. Oversees analytical method validation and analytical transfer activities across the program lifecycle.

Responsibilities

• Serve as QC QA Subject Matter Expert and drive a culture of quality to ensure compliance with FDA, EMA, and internal SOPs.
• Lead QA review/approval of analytical development, qualification/validation, and analytical technical transfer activities.
• Ensure stability programs follow established protocols and regulations; review regulatory submissions and assist with regulatory responses.
• Ensure proper RCA and CAPA for OOS/OOT results.
• Perform/lead QA review/approval of QC documentation for deviations, OOS/OOT, and change control.
• Provide QA operational oversight for internal QC labs and external contract testing labs; draft/enforce Quality Agreements.
• Use digital quality/data systems and AI-enabled solutions (e.g., MES, LIMS, eQMS, data visualization, advanced analytics) for quality oversight.
• Act as SME during audits/inspections; support/lead QA risk management and continuous improvement; support SOP/policy development; develop quality metrics at contract organizations.

Qualifications & Skills

• In-depth GxP QA/QC knowledge in cell therapies; strong understanding of regulatory environment and GMP/quality systems.
• Experience with MES/LIMS/eQMS and advanced analytics preferred.
• Prior experience running internal analytical labs and working with external test labs; experience in analytical method development.
• Ability to lead improvement projects (RCA, operational excellence such as LEAN/DMAIC/Six Sigma).
• Excellent communication; critical thinking/problem solving.

Education & Experience

• Master’s degree in a scientific/allied health field (or equivalent); PhD preferred.
• 8+ years’ experience in a regulated pharmaceutical environment.

Other Requirements

• Up to 15% travel.

Pay Range

$156,600 - $234,800