QA Validation Lead – CQV & GMP Compliance

ElevateBio; Waltham (MA); On-site; USD 105,000 - 145,000; Full time

Job summary

ElevateBio is a technology-driven company accelerating advanced therapies. We seek a Lead QAV Specialist to oversee commissioning, qualification, and validation (CQV) activities across GMP facilities and QC labs.

You will manage QA for validation master plans, project validation, and related deviations, CAPAs, and risk assessments. You will lead QA partnerships with Engineering teams, supervise CQV activities, and support Kneat, Veeva, and CMMS systems.

Qualifications

• Bachelor’s degree or higher with related experience as specified.
• Knowledge of 21 CFR, ICH, EU regulations.

Responsibilities

• Leads QA partnership for commissioning, qualification, and validation activities.
• Leads QA oversight of quality events for ongoing validation and engineering operations.
• Evaluates CQV change controls and provides QA support/approval.
• Oversees CMMS and evaluates quality impact for database modifications.
• Liaises with teams to develop project schedules and track milestones.
• Potential to administer Kneat electronic validation system.
• Leads QA oversight for periodic review and requalification activities.
• Manages QAV personnel including FTEs and contractors.
• Supports Equipment Relocation QA activities as needed.

Skills

QA oversight

CQV knowledge

GMP compliance

Validation

Risk assessment

Education

Bachelor’s degree or higher in a related field

Tools

Kneat

Veeva

Blue Mountain CMMS

Job description

ElevateBio is a technology-driven company accelerating advanced therapies. We seek a Lead QAV Specialist to oversee commissioning, qualification, and validation (CQV) activities across GMP facilities and QC labs.

You will manage QA for validation master plans, project validation, and related deviations, CAPAs, and risk assessments. You will lead QA partnerships with Engineering teams, supervise CQV activities, and support Kneat, Veeva, and CMMS systems.