Second-Shift Plant QA Lead (4x10h)

Replimune Group; Framingham (MA); On-site; USD 120,000 - 155,000; Full time

Benefits offered by this job

Annual bonus

New hire equity

Equity — performance-based

Medical/Dental/Vision insurance

401k match

Flexible time off

Paid holidays

Job summary

Replimune Group, Inc. in Framingham, MA, is seeking a Principal Associate I/II, Plant Quality Assurance. The role provides real-time quality oversight for Drug Substance/Drug Product and production QC testing, ensuring cGMP and GDP compliance across departments.

This 2nd shift position (Mon–Thu, 10-hour days) is based on-site with a 4-day on-site expectation. It demands strong QA leadership and cross-functional collaboration.

Qualifications

• BA or BS in a Science or related field or equivalent experience in the Quality function.
• 5-7+ years of experience in the pharmaceutical field including 5 years of Quality or Manufacturing experience.
• Experience in managing multiple, competing priorities in a fast-paced environment.
• Demonstrated proficiency of written and verbal communication skills.

Responsibilities

• Serve as the second shift QA lead working alongside manufacturing teams to ensure current and best practices are implemented, consistently maintaining compliance with cGMP standards and keeping the plant in compliance with corporate and regulatory quality requirements.
• Perform Quality walkthroughs and inspections on the floor, to maintain inspection readiness environment.
• Review and approve executed production batch records, logbooks, and QC Assays.
• Drive closure/completion of cGMP documents and records, including deviations, investigations, CAPA, change control, and validation documentation.
• Author/review/approve quality documents such as SOPs, risk assessments, training materials, engineering documents, automation documents, commissioning/validation materials.
• Conduct training on procedures, standard work, safety, and cGMP topics.

Skills

Quality Oversight

cGMP

GDP

Documentation

Communication

Education

Bachelor's degree in Science

Job description

Replimune Group, Inc. in Framingham, MA, is seeking a Principal Associate I/II, Plant Quality Assurance. The role provides real-time quality oversight for Drug Substance/Drug Product and production QC testing, ensuring cGMP and GDP compliance across departments.

This 2nd shift position (Mon–Thu, 10-hour days) is based on-site with a 4-day on-site expectation. It demands strong QA leadership and cross-functional collaboration.