Operational Area Quality Senior Specialist (Contract)

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

Job Description

The GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities and supports new/existing project initiatives. This individual is primarily responsible for coordinating the delivery of Annual Product Quality Review (APQR) and Quarterly Product Quality trending.

This position reports directly to the Director of Quality Systems.

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Delivery of Annual Product Quality Reviews (APQRs) for all commercial products.
• Coordinates with SMEs to develop the scope and author content of APQRs.
• Ensures appropriate CAPA actions are identified.
• Ensures completed reports are approved and archived.
• Assist with executing and developing quarterly product quality trending for commercial products manufactured at Vertex and Contract Manufacturing Organizations.
• Assist with preparation of Quality Management Review materials.
• Identifies and facilitates continuous improvement efforts.
• Helps represent Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills.
• Support continuous improvement projects.

Required education level:

• Bachelor's degree in a scientific or allied health field or the equivalent combination of education and experience.

Required experience:

• Experience with event investigations (deviations), Root Cause Analysis (RCA), and CAPA.
• Experience with network-based applications such as Veeva.
• Knowledge of current industry trends and ability to use the latest technologies.

Required knowledge/skills:

• Experience supporting multiple projects/teams within stated objectives and timelines.
• Experience supporting cross-functional team members and collaborate effectively.
• Good communication skills (written and verbal) and the ability to exchange potentially complex information.
• Able to integrates activities with other groups, departments and project teams as needed.
• Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience and judgement based on precedent.
• Ability to work in a fast-paced environment and meet quality, accuracy, and timeliness objectives.
• Expanded conceptual knowledge of cGMP's in a pharmaceutical setting.

Contract Length: 12 months with the chance to extend.

Pay Range

$61/hr. - $69/hr.

Shift/Hours

Monday–Friday, hybrid role: three days in the office, two days at home.

No C2C or Third-Party Vendors