Operational Area Quality Senior Specialist

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

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.
• Assists with executing and developing quarterly product quality trending for commercial products manufactured at Vertex and Contract Manufacturing Organizations.
• Assists 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.
• Supports 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 collaborating effectively.
• Good communication skills (written and verbal) and the ability to exchange potentially complex information.
• Able to integrate 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.

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements