Senior GMP Quality & Compliance Specialist

Vertex Pharmaceuticals; Boston (MA); Hybrid; USD 174,790,000 - 197,713,000; Full time

Job summary

Vertex Pharmaceuticals in Boston is seeking a GMP Operational Quality Senior Specialist to support the APQR delivery and quarterly product quality trending within a fast-paced, regulated environment.

The role collaborates with SMEs, coordinates APQR content, CAPA actions, and archival of reports. It also supports quarterly trending, quality reviews, and continuous improvement across Vertex and contract manufacturers.

Qualifications

• Bachelor's degree in a scientific or allied health field.
• Experience with event investigations (deviations), RCA, and CAPA.
• Experience with network-based applications such as Veeva.
• Knowledge of current industry trends and ability to use the latest technologies.
• Experience supporting multiple projects/teams within stated objectives and timelines.
• Experience supporting cross-functional team members and collaborate effectively.
• Strong communication skills (written and verbal).
• Ability to work in a fast-paced environment with quality, accuracy, and timeliness objectives.
• Expanded conceptual knowledge of cGMPs in a pharmaceutical setting.

Responsibilities

• Delivery of APQRs for all commercial products.
• Coordinates with SMEs to develop the scope and content of APQRs.
• Ensures CAPA actions are identified and tracked.
• Ensures reports are approved and archived.
• Assist with quarterly product quality trending for products manufactured at Vertex and CMOs.
• Assist with preparing Quality Management Review materials.
• Identify and facilitate continuous improvement efforts.
• Represent Vertex Quality on cross-functional teams and communicate effectively.
• Support continuous improvement projects.

Skills

Communication skills

Cross-functional collaboration

Quality systems knowledge

cGMP knowledge

RCA & CAPA

Event investigations

Project coordination

Timeliness & accuracy

Education

Bachelor's degree in a scientific or allied health field

Tools

Veeva

Job description

Vertex Pharmaceuticals in Boston is seeking a GMP Operational Quality Senior Specialist to support the APQR delivery and quarterly product quality trending within a fast-paced, regulated environment.

The role collaborates with SMEs, coordinates APQR content, CAPA actions, and archival of reports. It also supports quarterly trending, quality reviews, and continuous improvement across Vertex and contract manufacturers.