QA Lead, Plant Operations — Pharma/Cell Therapy

RoslinCT US; Hopkinton (MA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Job summary

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization with a strong focus on quality and regulatory excellence. The Quality Assurance Lead, Plant Operations, will oversee QA activities at our Hopkinton, MA site and work to ensure compliant manufacturing operations.

This on-site role requires leadership, rigorous attention to detail, and collaboration across teams.

Qualifications

• 7+ years of QA experience in pharma/biotech with internal manufacturing.
• Leadership or supervisory experience.
• Strong knowledge of cGMP and ICH regulations/guidelines.

Responsibilities

• Supervise and lead Quality Assurance team, including coaching and mentoring.
• Coordinate day-to-day operations for the QA team, including batch record review and deviations.
• Provide QA support to manufacturing operations and ensure GMP compliance.
• Monitor implementation of QA procedures and identify improvement opportunities.
• Work cross-functionally to develop and approve manufacturing procedures/workflows.

Skills

Quality Assurance

Leadership

cGMP compliance

Problem solving

Communication skills

Microsoft Office

Tools

Microsoft Office

Job description

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization with a strong focus on quality and regulatory excellence. The Quality Assurance Lead, Plant Operations, will oversee QA activities at our Hopkinton, MA site and work to ensure compliant manufacturing operations.

This on-site role requires leadership, rigorous attention to detail, and collaboration across teams.