Associate Director, QA Manufacturing Technical Services (Biotech)

TL;DR

Associate Director, QA Manufacturing Technical Services (Biotech): Leading quality operations and deviation management for internal Cell & Gene manufacturing programs with an accent on compliance, root cause analysis, and cross-functional partnership. Focus on providing real-time quality oversight on the manufacturing floor and driving continuous improvement initiatives to ensure regulatory adherence and product safety.

Location: Must be based in Boston, MA (On-site role)

Salary: $156,600 - $234,800

Company

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

What you will do

• Lead and oversee the deviation management process from identification to closure, ensuring thorough investigation and documentation.
• Provide technical expertise for OOS/OOT investigations, root cause analysis, and implementation of CAPA.
• Partner with Manufacturing, Quality Control, MSAT, and Regulatory Affairs to ensure effective resolution of quality issues.
• Provide routine on-the-floor quality support, including real-time troubleshooting and guidance to operations personnel.
• Ensure all activities comply with global regulatory standards such as FDA, EMA, and cGMP.
• Prepare and present regular reports on deviation metrics to senior leadership.

Requirements

• Bachelor's degree in a biotech or life sciences field; Master's degree preferred.
• 8+ years of relevant industry experience in manufacturing, QA, or QC within a regulated pharmaceutical environment.
• In-depth knowledge of global regulatory agency requirements across the GXP life cycle in Cell & Gene therapy or Biologics.
• Substantial experience with electronic document management systems like Trackwise or Veeva.
• Proven track record of influencing and promoting a culture of quality across manufacturing operations.
• Must be able to work on-site five days per week in Boston, MA.

Nice to have

• Experience with Operational Excellence methodologies such as LEAN, DMAIC, or Six Sigma.
• Broad technical knowledge in aseptic manufacturing, fill/finish, and analytical assays.

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 focused on professional growth and wellbeing.