Senior GMP Analytical QA Lead

Vertex Pharmaceuticals; Boston (MA); On-site; USD 76,000 - 90,000; Full time

Job summary

Vertex Pharmaceuticals in Boston seeks a GMP QA Analytical Sr. Quality Specialist to serve as a subject matter expert in QA and compliance for the Analytical function. The role supports clinical and commercial programs and collaborates across teams to ensure rapid, accurate quality decisions.

This senior specialist conducts GMP reviews, helps with change control, investigations, CAPA, and quality metrics, and represents Analytical QA on cross-functional projects in a fast-paced environment.

Qualifications

• Bachelor's degree in a scientific field or equivalent
• 2–4 years of QA analytical or manufacturing experience
• Working knowledge of cGMPs, ICH, USP guidelines

Responsibilities

• Provides QA review of GMP data for stability and release of clinical products
• Conducts GMP document review (procedures, work instructions, specs, methods)
• Supports analytical method validation/verification/transfer for clinical products
• Drafts and enforces Quality Agreements with CMOs/Suppliers
• Supports change control assessment, implementation and closure; approves investigations/CAPAs
• Supports quality oversight of deviation, OOS/OOT investigations and risk mitigation
• Represents Analytical QA on cross-functional teams
• Collaborates with internal/external partners to resolve quality issues
• Assists in preparation of audit responses and participates in audit programs

Skills

Quality assurance

GMP knowledge

Analytical techniques

Change controls

Investigations RCA CAPA

Cross-functional collaboration

Communication skills

Document management systems

Education

Bachelor's degree in science

Tools

QDoccs

Trackwise

Veeva

Job description

Vertex Pharmaceuticals in Boston seeks a GMP QA Analytical Sr. Quality Specialist to serve as a subject matter expert in QA and compliance for the Analytical function. The role supports clinical and commercial programs and collaborates across teams to ensure rapid, accurate quality decisions.

This senior specialist conducts GMP reviews, helps with change control, investigations, CAPA, and quality metrics, and represents Analytical QA on cross-functional projects in a fast-paced environment.