Analytical Quality Assurance, Associate Director

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