Senior Specialist Small Molecule CMC Compliance (Contractor)

Job Description

Title/Role: Senior Specialist Small Molecule CMC Compliance  

General position summary:

The 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 Reviews.

This position reports to the Associate Director of Quality Small Molecule CMC Compliance

This is a 6 month contract with the chance to extend.

KEY RESPONSIBILITIES:

• Delivery of Annual Product Reviews (APRs) for all commercial products
• Coordinates with SMEs to develop the scope and author content of APRs
• Authors relevant APR sections (e.g. Purpose, Executive Summary, and Conclusions)
• Ensures appropriate CAPA actions are identified.
• Ensures completed reports are approved and archived
• Assist with executing quarterly quality trending for commercial products manufactured at Vertex and Contract Manufacturing Organizations
• Helps represent Vertex Quality on cross-functional working teams, applying strong communication and collaboration skills.
• Support continuous improvement projects

KEY TECHNICAL KNOWLEDGE, SKILLS AND COMPETENCIES:

• Experience facilitating & authoring Annual Product Reviews/Annual Product Quality Reviews in support of commercial pharmaceutical products
• 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
• Proficient in leading event investigations, Root Cause Analysis (RCA), and CAPA

Minimum qualifications:

• Bachelor's degree in scientific or allied health field (or equivalent degree)
• Typically requires 2 years of experience, or the equivalent combination of education and experience

Pay Range

based on experience 

Requisition Disclaimer

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

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No C2C or Third-Party Vendors