Senior Quality Analytics & APQR Specialist

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 84,000 - 95,000; Full time

Job summary

Vertex Pharmaceuticals LLC in Boston, MA is seeking a GMP Operational Quality Senior Specialist to support QA and regulatory compliance, focusing on APQR delivery and quarterly product quality trending. The role reports to the Director of Quality Systems and involves cross-functional collaboration in a hybrid, 3 days in-office schedule.

The position requires a Bachelor's degree in a scientific field, experience with deviations/RCA/CAPA, and familiarity with Veeva and cgMP practices.

Qualifications

• Bachelor's degree in a scientific or allied health field or the equivalent combination of education and experience.
• Experience with event investigations (deviations), Root Cause Analysis (RCA), and CAPA.
• Expanded knowledge of cGMPs in a pharmaceutical setting.
• Experience supporting multiple projects/teams within stated objectives and timelines.
• Good communication skills (written and verbal) and the ability to exchange potentially complex information.

Responsibilities

• Delivery of Annual Product Quality Reviews (APQRs) for all commercial products.
• Coordinates with SMEs to develop the scope and content of APQRs.
• Ensures appropriate CAPA actions are identified and tracked.
• Ensures completed APQRs are approved and archived.
• Assist with quarterly product quality trending for commercial products.
• Assist with preparation of Quality Management Review materials.
• Identify and facilitate continuous improvement efforts.
• Represent Vertex Quality on cross-functional teams and collaborate effectively.
• Support continuous improvement projects.

Skills

CAPA processes

Cross-functional collaboration

Root Cause Analysis

Regulatory compliance

Excellent communication

Education

Bachelor's degree

Tools

Veeva

Quality Management System

Job description

Vertex Pharmaceuticals LLC in Boston, MA is seeking a GMP Operational Quality Senior Specialist to support QA and regulatory compliance, focusing on APQR delivery and quarterly product quality trending. The role reports to the Director of Quality Systems and involves cross-functional collaboration in a hybrid, 3 days in-office schedule.

The position requires a Bachelor's degree in a scientific field, experience with deviations/RCA/CAPA, and familiarity with Veeva and cgMP practices.