Associate Director, Shift Quality Operations; Onsite

Associate Director – Shift Quality Operations

The Associate Director - Shift Quality Operations is an advanced technical resource in the principles and application of quality assurance and compliance. The Associate Director provides quality leadership and oversight for manufacturing operations conducted across assigned shifts for cell therapy manufacturing. This role is responsible for ensuring ongoing compliance with cGMP, aseptic processing requirements, site quality systems, and regulatory expectations while enabling safe, reliable, and efficient manufacturing.

The position partners closely with Manufacturing, Quality Assurance, Quality Control, MSAT, Engineering, Validation, and Supply Chain to support batch execution, deviation management, investigations, line clearance, contamination control, and continuous improvement. The Associate Director also leads and develops a team of quality professionals providing real‑time shop floor quality oversight.

This On‑Site role is located at Vertex's VMC

Quality Oversight

• Provide shift‑based QA oversight for aseptic manufacturing operations, including formulation, filling, inspection, and supporting activities as applicable.
• Ensure manufacturing activities are executed in compliance with cGMP, GDP, site procedures, and aseptic processing standards.
• Serve as the primary quality representative for escalating critical quality issues appropriately.
• Support batch disposition readiness through review of manufacturing documentation, events, and quality observations.
• Demonstrated understanding of digital quality systems, data management, automation, and emerging AI technologies within regulated GxP environments.
• Responsible for using platforms such as MES, LIMS, eQMS, data visualization tools, and advanced analytics to perform Quality oversight.

Aseptic Operations Support

• Oversee quality execution for critical aseptic operations, material flow and contamination control practices, line clearance, and cell therapy manufacturing including chain of custody and identity.
• Ensure adherence to Contamination Control Strategy (CCS) and aseptic behaviors on the manufacturing floor.
• Provide real‑time decision‑making support during quality events and atypical situations.

Deviation, Investigation, and CAPA Management

• Lead or support deviation triage, investigation, root cause analysis, impact assessments, and CAPA development.
• Ensure quality issues are documented, investigated, and closed in a timely and compliant manner.
• Identify recurring issues and drive sustainable improvements to prevent repeat events.
• Expertise in utilizing eQMS platforms for QMS activities.

Team Leadership

• Lead, coach, and develop a team of shift quality professionals.
• Establish clear goals, performance expectations, and development plans.
• Promote a culture of quality, accountability, inspection readiness, and continuous improvement.
• Ensure adequate shift coverage and effective handoff across shifts.

Inspection Readiness and Compliance

• Maintain a constant state of inspection readiness for aseptic manufacturing areas.
• Support internal audits, regulatory inspections, and client audits.
• Ensure observations are addressed promptly and effectively.

Cross‑Functional Collaboration

• Partner with site leadership and cross‑functional teams to support:
  • Production schedule adherence
  • Product quality
  • Operational excellence
  • Tech transfer/startup activities
  • Process improvements
  • Act as a trusted advisor on quality risk and compliance decisions.

• Bachelor's degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or related discipline required.
• Preferred master's degree or relevant comparable background.

• 8+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.
• 5+ years of experience supporting aseptic manufacturing, sterile operations, or parenteral production.
• Prior people leadership or supervisory experience strongly preferred.
• Experience with shop floor QA oversight in a commercial or late‑stage clinical manufacturing environment…