Associate Director, Analytical Quality Assurance (Biotech)

TL;DR

Associate Director, Analytical Quality Assurance (Biotech): Providing quality oversight for analytical development and quality control activities in Cell & Gene programs with an accent on compliance, method validation, and stability testing. Focus on driving quality culture, managing deviations/CAPAs, and leveraging digital/AI-enabled tools for operational excellence.

Location: On-site in Boston, MA (5 days per week)

Salary: $156,600–$234,800

Company

A global biotechnology company dedicated to scientific innovation and developing transformative medicines.

What you will do

• Provide QA oversight for analytical development, qualification, validation, and technical transfer activities.
• Ensure stability programs comply with established protocols and regulatory requirements.
• Lead root cause analysis and approve investigations for OOS and OOT results.
• Manage quality agreements and operational oversight for internal and external contract testing laboratories.
• Utilize digital systems like LIMS, eQMS, and AI-enabled tools to improve quality oversight and decision-making.
• Represent QA as a subject matter expert during regulatory audits and inspections.

Requirements

• Master’s degree in a scientific or allied health field required (Ph.D. preferred).
• 8+ years of experience in a regulated pharmaceutical environment.
• In-depth knowledge of global regulatory agencies and GXP QA/QC activities in cell therapies.
• Experience with analytical method development and running internal/external analytical labs.
• Proven track record in root cause analysis and operational excellence methodologies (LEAN, Six Sigma).
• Must be able to work on-site in Boston, MA, 5 days per week.

Nice to have

• Experience with MES, LIMS, and eQMS platforms.
• Advanced data visualization and analytics skills.

Culture & Benefits

• Comprehensive medical, dental, and vision benefits.
• Generous paid time off, including company-wide summer and winter shutdowns.
• Educational assistance programs including student loan repayment.
• 401(k) retirement plan with company matching.
• Supportive environment with a focus on flexibility and professional growth.