Lead Specialist, QA Validation (Biotech)

Location: Waltham, Massachusetts, United States

Salary: $50–$69 per hour

Company

Technology-driven biotechnology company providing integrated technologies, end-to-end services, and manufacturing expertise for advanced therapies from design through commercialization.

What you will do

• Lead QA oversight for commissioning, qualification, and validation activities across a GMP manufacturing facility and quality control laboratories.
• Act as the QA subject matter expert and escalation point for validation, engineering, manufacturing equipment, utilities, automation, computer systems, and laboratory instruments.
• Review and approve change controls, impact assessments, deviations, CAPAs, risk assessments, and technical reports related to CQV activities.
• Oversee CMMS quality impacts, periodic reviews, requalification activities, and potential administration of the Kneat electronic validation system.
• Coordinate project schedules, milestones, issue escalation, and adherence to program timelines.
• Manage QAV personnel, including employees and contractors, and support equipment relocation activities.

Requirements

• Bachelor’s degree with at least 5 years of related experience, Master’s degree with at least 3 years, or PhD with up to 1 year of related experience.
• Strong knowledge of 21 CFR, ICH, and EU regulations.
• Experience with technical writing and computer tools including Word, Excel, PowerPoint, Kneat, Veeva, and Blue Mountain CMMS.
• Ability to apply risk-based decisions, negotiate effectively, and solve problems flexibly.
• Ability to stand, walk, bend, stretch, kneel, twist, climb step ladders while wearing PPE, lift 15–20 lbs, and perform repetitive movements.

Nice to have

• Cell and gene therapy manufacturing experience.
• Management experience.
• Experience commissioning and qualifying new facilities.
• Experience with Blue Mountain CMMS.

Culture & Benefits

• Collaborative, team-based environment focused on continuous improvement and achievement of quality goals.
• Regular employment position within the Quality Assurance department.
• Open, clear, complete, timely, and consistent communication is expected.