Manufacturing Process & Technical Quality Associate Director (Biotech)

TL;DR

Manufacturing Process & Technical Quality Associate Director (Biotech): Technical quality oversight of cell and genetic programs throughout development and commercialization with an accent on establishing product quality standards and ensuring regulatory alignment. Focus on identifying product quality risks, managing CMC governance, and driving continuous improvements in manufacturing processes.

Location: Boston, MA. Hybrid-Eligible (work remotely up to two days per week) or On-Site.

Company

Vertex is a global biotechnology company that invests in scientific innovation.

What you will do

• Lead the development and implementation of Quality compliance principles and CMC Quality standards for the Cell & Genetic Therapies portfolio.
• Identify and mitigate quality risks and gaps, handling OOS and risk resolution with cross-functional partners.
• Maintain quality and compliance frameworks in alignment with industry standards, health authority expectations, and the internal QMS.
• Drive manufacturing and compliance continuous improvements from clinical development to commercial lifecycle.
• Serve as the Quality SME on CMC Governance teams for technical transfers and new product introductions.
• Prepare for and support Health Authority inspections and negotiate required corrective actions.

Requirements

• Must be based in or able to work in Boston, MA.
• Bachelor's degree in a scientific or allied health field.
• Typically 8+ years of work experience and 2 years of management experience.
• In-depth knowledge of GXP life cycle in Cell & Gene therapy and/or Biologics (ICH/EU/FDA).
• Direct experience with regulators and submissions such as NDA, BLA, or MAA.
• Technical expertise in AAV/Cell technology and aseptic processing.

Nice to have

• Experience with Root Cause Analysis and data analytics.
• Operational Excellence certifications such as LEAN, DMAIC, or Six Sigma.

Culture & Benefits

• Comprehensive medical, dental, and vision benefits.
• Generous paid time off, including company-wide shutdowns in Summer and Winter.
• 401(k) plan and matching charitable donations.
• Educational assistance and student loan repayment programs.
• Commuting subsidy for office-based work.