Senior Quality Engineer Responsibilities:

Quality Oversight & GMP Operations

• Provide Quality Assurance oversight for GMP manufacturing operations supporting both clinical and commercial Cell & Gene Therapy products.
• Partner with Manufacturing, Validation, Engineering, Facilities, Laboratory Operations, Materials Management, and Capital Project teams to ensure GMP compliance throughout the product lifecycle.
• Represent Quality on cross-functional project teams while serving as the primary QA resource for assigned initiatives.
• Identify compliance risks and proactively communicate quality gaps, recommending practical, risk-based solutions.

Validation & Engineering Support

• Provide QA review and approval of:
  • Validation protocols and reports
  • Equipment, utility, facility, and computer system qualification documentation
  • Risk assessments
  • Engineering change documentation
• Support commissioning, qualification, and validation activities associated with manufacturing equipment, facilities, utilities, and capital projects.
• Review qualification activities for laboratory instruments and manufacturing systems.

Quality Systems & Compliance

• Provide Quality support for:
  • Change Controls
  • Deviations and GMP Investigations
  • Root Cause Analysis
  • Corrective and Preventive Actions (CAPA)
• Ensure investigations are scientifically sound, timely, and compliant with regulatory expectations.
• Evaluate quality issues using a risk-based decision-making approach.

Facilities & Utility Oversight

• Provide Quality oversight for:
  • Preventive Maintenance (PM)
  • Calibration programs
  • Electronic Change Requests (eCRs)
  • Work Orders
• Review and approve equipment, utility, and facility trending programs.
• Support Environmental Monitoring (EM), routine facility monitoring, and utility control programs.
• Provide oversight of facility monitoring systems including Building Management Systems (BMS), Environmental Monitoring Systems (EMS), ViewLinc, pest control, and related GMP-controlled programs.

Cross-Functional Collaboration

• Foster strong collaboration across Quality, Manufacturing, Engineering, Validation, Facilities, and Laboratory organizations.
• Participate in project meetings and provide quality guidance throughout project execution.
• Communicate effectively with stakeholders at all organizational levels while balancing quality, compliance, and business objectives.

Requirements:

• Master's degree with 3–5 years of relevant Quality or Validation experience OR
• Bachelor's degree in Engineering, Life Sciences, Scientific, or related discipline with 8+ years of relevant industry experience, or equivalent combination of education and experience.
• Experience providing QA oversight of GMP manufacturing operations.
• Experience supporting validation programs and capital projects within regulated pharmaceutical, biotechnology, or Cell & Gene Therapy environments.
• Strong knowledge of cGMP regulations, quality systems, and validation principles.
• Experience supporting aseptic manufacturing operations.
• Demonstrated experience leading:
  • GMP investigations
  • Root Cause Analysis
  • CAPA development and effectiveness
• Experience reviewing validation documentation, engineering documentation, and quality system records.
• Experience working with electronic quality systems such as:
  • Veeva
  • Nuvolo
  • ViewLinc
  • Other enterprise GMP quality applications
• Onsite job requirement in Boston, MA