Senior Product Quality Lead – GMP & Tech Transfer

RoslinCT US; Hopkinton (MA); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Program

Educational Assistance

Job summary

RoslinCT is seeking a Principal - Product Quality Lead to represent QA on client projects, oversee product quality from NPI through commercial manufacture in a multi-product facility. You will drive technical transfer, change controls, and regulatory alignment with FDA/EMA expectations.

This client-facing role requires excellent communication, GMP expertise, and a track record of collaborating across QA, Manufacturing, and QC to ensure compliant, high-quality products.

Qualifications

• Thorough knowledge of GMP regulations (FDA/EMA) required.
• Experience supporting early development through commercialization.
• Proficiency with electronic QMS software.

Responsibilities

• Represent Quality Assurance on technical transfer teams and provide QA oversight through product lifecycle.
• Quality Approver for product-related change controls.
• Review and approve controlled documents (Mfg, QC, QA) in alignment with timelines.

Skills

GMP Regulations

QA Oversight

Tech Transfer

Regulatory Interaction

Documentation Review

Continuous Improvement

Education

Bachelor's degree in Life Sciences

Tools

Electronic QMS

Job description

RoslinCT is seeking a Principal - Product Quality Lead to represent QA on client projects, oversee product quality from NPI through commercial manufacture in a multi-product facility. You will drive technical transfer, change controls, and regulatory alignment with FDA/EMA expectations.

This client-facing role requires excellent communication, GMP expertise, and a track record of collaborating across QA, Manufacturing, and QC to ensure compliant, high-quality products.