Quality & Compliance Specialist – APQR & CAPA (Hybrid)

Atrium; Boston (MA); Hybrid; USD 84,000 - 95,000; Full time

Job summary

Vertex Pharmaceuticals is seeking a GMP Operational Quality Senior Specialist to coordinate APQR delivery and quarterly quality trending in a hybrid Boston role. The position reports to the Director of Quality Systems and supports cross-functional teams to drive CAPA actions and process improvements.

The ideal candidate has experience in deviations, RCA, CAPA, and cGMPs within pharma, and a Bachelor's degree in a scientific field.

Qualifications

• Experience with event investigations (deviations), RCA, and CAPA.
• Knowledge of cGMPs in a pharmaceutical setting.
• Ability to support multiple projects and timelines.

Responsibilities

• Delivery of APQRs for all commercial products.
• Coordinates with SMEs to develop APQR scope and content.
• Ensures CAPA actions are identified and tracked.
• Ensures reports are approved and archived.
• Assists with quarterly product quality trending for products at Vertex and CMOs.
• Assists with Quality Management Review materials.
• Identifies and facilitates continuous improvement efforts.
• Represents Vertex Quality on cross-functional teams.

Skills

Cross-functional collaboration

Communication skills

Problem solving

Education

Bachelor's degree in a scientific or allied health field

Tools

Veeva

Job description

Vertex Pharmaceuticals is seeking a GMP Operational Quality Senior Specialist to coordinate APQR delivery and quarterly quality trending in a hybrid Boston role. The position reports to the Director of Quality Systems and supports cross-functional teams to drive CAPA actions and process improvements.

The ideal candidate has experience in deviations, RCA, CAPA, and cGMPs within pharma, and a Bachelor's degree in a scientific field.